Cap
2 catalogue numbers from 100-005-631, listed by Genicon, Inc., United States, under Cannula, Surgical, General & Plastic Surgery. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
2catalogue numbers in this listing
14recalls on this code
Who Else Makes It
Concentrated in Zhejiang (7), Shanghai (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | Jiading | Shanghai | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Ningbo Hanyue Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Showing 12 of 14. All 14 manufacturers in China registered for Cannula, Surgical, General & Plastic Surgery
Record
| Listed by | Genicon, Inc., United States |
|---|---|
| FDA product code | GEA |
| Device type | Cannula, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| 510(k) | K982472 |
| Record published | 2017-05-05 |
| Record revised | 2024-07-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-005-631 | In distribution | |
| 100-010-744 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | Black & Black Surgical, Inc. | 1,600 |
| Summit Medical | Summit Medical LLC | 988 |
| Medco Manufacturing | Medco Manufacturing LLC | 562 |
| Hayden Medical | Hayden Medical Inc | 457 |
| Cannula, Surgical, General & Plastic Surgery | Shippert Medical Technologies Corp. | 452 |
| Boss Instruments | Boss Instruments, Ltd. | 436 |
| Millennium | Avalign Technologies, Inc. | 281 |
| Black & Black Surgical | Black & Black Surgical, Inc. | 227 |
| Alira Medical Devices | Alira Medical Devices LLC | 157 |
| Black & Black Surgical, Inc. | Black & Black Surgical, Inc. | 154 |
| Aesculap | Aesculap AG | 134 |
| Euromi | Euromi | 126 |
Showing 12 of 608. All products under Cannula, Surgical, General & Plastic Surgery
Recalls Naming This Product
15 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 378 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 48 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 42 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 2 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 74 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 12 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 28 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 3 box (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 106 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 102 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 10 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 17 boxes (5 units per box) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 0 (6 boxes with 5 units/per box in inventory) | |
| Genicon, Inc. | 510(k) number | 2018-08-21 | Class II | Process control | There is potential for the plastic optical tip to become detached from the metal shaft. | 0 (24 boxes with 5 units/box in inventory) | |
| Genico, Inc., dba Genicon | 510(k) number | 2008-09-25 | Not classified | Manufacturing material removal | The stainless steel tips on the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and there was also pitting on the tip of the trocar. | 2,965 units (1340 OUS and 1625 US) | 2009-01-09 |
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.