Disposable HOT Biopsy Forceps

Olympus Disposable HOT Biopsy Forceps collect tissue samples from the digestive tract under endoscopic observation. Distal cups hold the tissue while high-frequency electrical current…

Registry build 21.09.26

Olympus Disposable HOT Biopsy Forceps collect tissue samples from the digestive tract under endoscopic observation. Distal cups hold the tissue while high-frequency electrical current supports tissue collection.

The forceps have an insertion portion and a handle with a slider that opens and closes the cups. An A-cord connects the handle plug to a compatible electrosurgical device.

Cup Designs and Supply

FD-210U uses an alligator jaw-step cup, while FD-230U uses an oval cup. Both have a 2.2 mm cup diameter and a 2,300 mm working length. The forceps are single-use devices sterilized by gamma radiation.

3manufacturers in China registered for this device type
6catalogue numbers in this listing
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Beijing (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code KGE
Manufacturer City Province Registered as Device types
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19

Record

Regulatory record for Disposable HOT Biopsy Forceps
Listed by Olympus Medical Systems Corp., Japan
FDA product code KGE
Device type Forceps, Biopsy, Electric
Device class Class 2
Regulation 21 CFR 876.4300
Establishment Specification developer, Manufacturer, Exporter
510(k) K250187
Record published 2016-09-21
Record revised 2026-06-01 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Pack of 5, pack of 16
Distribution end date 2022-08-09

Catalogue Numbers

Catalogue numbers for Disposable HOT Biopsy Forceps
Catalogue number Size Status
FD-230U In distribution
FD-210U In distribution
FD-230U In distribution
FD-210U In distribution
FD-230U Withdrawn
FD-210U Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Forceps, Biopsy, Electric Karl Storz GmbH & Co. KG 32
Zksk Beijing Zksk Technology Co., Ltd. 16
Fujifilm Fujifilm Corporation 15
Fujifilm Diathermic Slitter (FlushKnife) Fujifilm Corporation 13
Forceps, Biopsy, Electric Hangzhou AGS MedTech Co., Ltd. 12
Halyard Avanos Medical, Inc. 9
Single Use Electrosurgical Hemostatic Forceps Olympus Medical Systems Corp. 7
Biopsy Forcep Avanos Medical, Inc. 6
Ensure(TM) Single-Use Coagulation Forceps Micro-Tech (Nanjing) Co., Ltd. 6
ClearHemograsper Finemedix 5
Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) Co., Ltd. 4
Precisor ConMed Corporation 4

Showing 12 of 31. All products under Forceps, Biopsy, Electric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K251807 2026-03-06
K250187 2025-10-07
K171916 2017-10-13
K062517 2006-12-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer