HOT Biopsy Forceps
FD-1U-1.B HOT Biop Frcps
3manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Beijing (1), Zhejiang (1).
| 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
| 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 |
| Record published | 2016-09-21 |
| Record revised | 2023-01-16 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-08-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FD-1U-1 | In distribution | |
| FD-1L-1 | Withdrawn |
Same 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 |
| Disposable HOT Biopsy Forceps | Olympus Medical Systems Corp. | 6 |
| 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 |
Showing 12 of 31. All products under Forceps, Biopsy, Electric
510(K) Clearances
| 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.