Zksk
Disposable Hot Biopsy Forceps
3manufacturers in China registered for this device type
16catalogue numbers in this listing
1510(k) clearance
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 | Beijing Zksk Technology Co., Ltd., China |
|---|---|
| FDA product code | KGE |
| Device type | Forceps, Biopsy, Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4300 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2023-12-18 |
| Record revised | 2024-08-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HF18-18/200 | In distribution | |
| HF18-A24/60 | In distribution | |
| HF18-24/160 | In distribution | |
| HF18-18/180 | In distribution | |
| HF18-24/120 | In distribution | |
| HF18-24/180 | In distribution | |
| HF18-18/60 | In distribution | |
| HF18-18/160 | In distribution | |
| HF18-24/60 | In distribution | |
| HF18-24/200 | In distribution | |
| HF18-24/230 | In distribution | |
| HF18-A24/180 | In distribution | |
| HF18-A24/230 | In distribution | |
| HF18-18/120 | In distribution | |
| HF18-A24/160 | In distribution | |
| HF18-A24/120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Forceps, Biopsy, Electric | Karl Storz GmbH & Co. KG | 32 |
| 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 |
| Precisor | ConMed Corporation | 4 |
Showing 12 of 31. All products under Forceps, Biopsy, Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231721 | 2023-12-14 |
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.