Instrument, Biopsy
The disposable Biopsy Forceps Enteroscope are used to obtain mucosal tissue samples during endoscopic procedures.
9manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Us Endoscopy, United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K924106 |
| Record published | 2020-04-01 |
| Record revised | 2020-03-17 (version 5) |
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, manufacturing date |
| Storage | Special storage condition: Keep Dry |
| Packaging | Case of 5, box of 5 |
| Sizes | Outer diameter 1.8 to 2.5 mm; length 160 to 350 cm |
| Distribution end date | 2022-11-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00711261 | Outer Diameter 1.8 mm | Withdrawn |
| 00711205 | Outer Diameter 2.5 mm | Withdrawn |
| 00711203 | Outer Diameter 2.3 mm | Withdrawn |
| 00711204 | Outer Diameter 2.3 mm | Withdrawn |
| 00711202 | Outer Diameter 2.3 mm | Withdrawn |
| 00711205 | Length 230 cm | Withdrawn |
| 00711261 | Length 160 cm | Withdrawn |
| 00711201 | Length 230 cm | Withdrawn |
| 00711204 | Outer Diameter 2.3 mm | Withdrawn |
| 00711203 | Outer Diameter 2.3 mm | Withdrawn |
| 00711291 | Outer Diameter 2.3 mm | Withdrawn |
| 00711262 | Outer Diameter 1.8 mm | Withdrawn |
| 00711202 | Length 230 cm | Withdrawn |
| 00711262 | Length 160 cm | Withdrawn |
| 00711291 | Length 350 cm | Withdrawn |
| 00711201 | Outer Diameter 2.3 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | 157 |
| CorVocet™ | Merit Medical Systems, Inc. | 157 |
| SureCore Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 108 |
| M Biopsy Coaxial Biopsy Needle | Canyon Medical Inc. | 89 |
| Co-Axial Introducer Needle | Argon Medical Devices, Inc. | 80 |
| SureCore Semi-automatic Disposable Biopsy Needle | Canyon Medical Inc. | 76 |
| Invivo | Philips DS North America LLC | 71 |
| Coaxial needle | Möller Medical GmbH | 68 |
| Disposable needle for reusable biopsy gun | Möller Medical GmbH | 62 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 60 |
Showing 12 of 692. All products under Instrument, Biopsy
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.