Health Microport Disposable Biopsy Forceps

FDA Class I | 510(k) Exempt | Product Code FCL | Single Use | Rx Only

The Disposable Biopsy Forceps are a single-use endoscopic accessory for taking tissue samples from the gastrointestinal tract under endoscopic observation. They come in two outer diameters with oval or alligator cup jaws, with or without a needle, to suit different endoscope channels and sampling needs.

Key Features

Rigid quad-pole connection. The rigid four-link jaw structure opens and closes firmly, which makes tissue sampling easier and more reliable.

Sharp, intact cutting edge. The jaw blades are precision-formed to give clean tissue separation with each bite.

Large-capacity cup. The oversized jaw cup collects an adequate sample in fewer passes.

Jaw options. Oval cup and alligator cup jaws are available, each with or without a center needle. The needle helps anchor the forceps on the tissue during sampling.

Rotatable handle . A synchronous rotating handle lets the operator orient the jaws precisely at the target site.

Smooth outer coating . A super-smooth coating on the shaft reduces wear on the endoscope working channel.

Single-use design. Each device is used once. This removes the need for reprocessing and lowers the risk of cross-contamination between patients.

Intended Use

Tissue sampling from the gastrointestinal tract under endoscopic observation.

Specifications

Oval Cup – Without Needle ┃ Model Number: HM/101-A-23/1600 2300 (S) ┃ O.D.: 2.3 mm ┃ Length: 1600 2300 mm ┃ Endoscope Channel: 2.8 mm

Oval Cup – With Needle ┃ Model Number: HM/101-B-23/1600 2300 (S) ┃ O.D.: 2.3 mm ┃ Length: 1600 2300 mm ┃ Endoscope Channel: 2.8 mm

Alligator Cup – Without Needle ┃ Model Number: HM/101-C-23/1600 2300 (S) ┃ O.D.: 2.3 mm ┃ Length: 1600 2300 mm ┃ Endoscope Channel: 2.8 mm

Alligator Cup – With Needle ┃ Model Number: HM/101-D-23/1600 2300 (S) ┃ O.D.: 2.3 mm ┃ Length: 1600 2300 mm ┃ Endoscope Channel: 2.8 mm

Oval Cup – Without Needle ┃ Model Number: HM/101-A-18/1200 1600 (S) ┃ O.D.: 1.8 mm ┃ Length: 1200 1600 mm ┃ Endoscope Channel: 2.0 mm

Oval Cup – With Needle ┃ Model Number: HM/101-B-18/1200 1600 (S) ┃ O.D.: 1.8 mm ┃ Length: 1200 1600 mm ┃ Endoscope Channel: 2.0 mm

Alligator Cup – Without Needle ┃ Model Number: HM/101-C-18/1200 1600 (S) ┃ O.D.: 1.8 mm ┃ Length: 1200 1600 mm ┃ Endoscope Channel: 2.0 mm

Alligator Cup – With Needle ┃ Model Number: HM/101-D-18/1200 1600 (S) ┃ O.D.: 1.8 mm ┃ Length: 1200 1600 mm ┃ Endoscope Channel: 2.0 mm

Regulatory Information

For professional use only. Sold exclusively to hospitals, clinics, and other licensed healthcare institutions. Read the Instructions for Use before use.

Warranty Policy

Medaza, Inc.

1. Product Scope

This product is intended solely for use by licensed clinics, hospitals, laboratories, and research facilities for professional or institutional human-use applications. It is not labeled, marketed, or warranted for consumer or home use, and is not intended for resale to individual end users.

2. Limited Manufacturer Warranty

This product is warranted by the original manufacturer to be free from defects in materials and workmanship at the time of shipment, when stored, handled, and used in accordance with the manufacturer's Instructions for Use (IFU) and labeling.

3. Single-Use / Consumable Exclusion

This is a single-use, sterile medical consumable intended for one-time use. As a consumable product, it is:

Not covered by any warranty once the sterile packaging has been opened, the product has been used, or the expiration/use-by date has passed
Not eligible for return, replacement, or refund based on buyer's change of mind, over-ordering, or discontinued use, once shipped and accepted
Excluded from any implied warranty of merchantability or fitness for a particular purpose beyond what is required by applicable law

4. What IS Covered

Notwithstanding Section 3, this warranty does apply, and Medaza, Inc. will facilitate a replacement, credit, or refund through the manufacturer, where:

The product arrives with compromised sterile packaging (torn, punctured, or improperly sealed) at time of receipt
The product exhibits a manufacturing defect present prior to use (e.g., material failure, dimensional nonconformity, malfunction not attributable to misuse, improper storage, or mishandling by buyer)
The product was not as described on the invoice or packing slip (wrong configuration, size, or gauge shipped in error)

Claims under this section must be submitted within 3 business days of receipt (unopened packaging defects) or promptly upon discovery of a manufacturing defect, and must include lot number, photographs, and a description of the issue. Medaza, Inc. reserves the right to require return of the affected unit(s) for manufacturer inspection prior to issuing replacement or credit.

5. Exclusions

This warranty does not cover damage or nonconformity resulting from:

Improper storage (e.g., temperature excursion, exposure to moisture or contaminants)
Use beyond the labeled expiration date
Improper handling, technique, or clinical misuse
Alteration or modification of the product by buyer or any third party
Normal wear expected in single-use consumables

6. Field Safety Corrective Actions and Recalls

In the event the manufacturer or a regulatory authority (including but not limited to the U.S. FDA Center for Devices and Radiological Health, or applicable state authority) issues a recall, field safety notice, or field safety corrective action affecting this product:

Medaza, Inc. will notify affected buyers using the contact and shipment records on file, relying on lot/batch traceability maintained under Medaza, Inc.'s Quality Management System
Buyers are required to immediately quarantine and cease use of any affected lots upon notification, and to cooperate with return, disposition, or reporting instructions provided
Buyers must report any adverse events or product complaints associated with this product to Medaza, Inc. promptly, so that Medaza, Inc. can fulfill its complaint-handling obligations to the manufacturer and, where applicable, to regulatory authorities
Participation in a recall or field safety corrective action does not waive, and is separate from, the warranty terms above — recalled product is addressed under recall procedures, not warranty claims

7. Limitation of Liability

Except as expressly stated above, this product is provided on an "as-is" basis to the extent permitted by applicable law. Medaza, Inc.'s liability under this warranty is limited to replacement, credit, or refund of the affected unit(s), and Medaza, Inc. is not liable for indirect, incidental, or consequential damages arising from use of this product.

8. Governing Terms

This Warranty Policy operates alongside, and does not limit, Medaza, Inc.'s Terms of Service, Shipping Policy, and applicable human medical device regulatory obligations under DSHS and FDA frameworks, including, where applicable, FDA 510(k) clearance requirements.