Surgistar
142 catalogue numbers from 8521, listed by Surgistar, Inc., United States, under Scalpel, One-Piece. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
142catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 28 |
| Anhui Yixiang Trading Co., Ltd. | Hefei | Anhui | Repacker / relabeller | 13 |
| Huaian Angel Medical Instrument Co., Ltd. | Huaian | Jiangsu | Manufacturer | 11 |
Showing 12 of 14. All 14 manufacturers in China registered for Scalpel, One-Piece
Record
| Listed by | Surgistar, Inc., United States |
|---|---|
| FDA product code | GDX |
| Device type | Scalpel, One-Piece |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K923689 |
| Record published | 2016-07-07 |
| Record revised | 2021-01-22 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6, pack of 12, pack of 10, pack of 4, pack of 3, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8521 | In distribution | |
| 2420 | In distribution | |
| 126-MINDE-1.5AD | In distribution | |
| 789115 | In distribution | |
| 7200 | In distribution | |
| 6600 | In distribution | |
| 7210 | In distribution | |
| 8101 | In distribution | |
| 6925 | In distribution | |
| 5230 | In distribution | |
| 2300 | In distribution | |
| 6200 | In distribution | |
| 4900 | In distribution | |
| S6500 | In distribution | |
| 7522 | In distribution | |
| 8234 | In distribution | |
| 960011 | In distribution | |
| 2410 | In distribution | |
| 6811 | In distribution | |
| 5700S | In distribution | |
| 5940 | In distribution | |
| 7515 | In distribution | |
| 6910 | In distribution | |
| 7120 | In distribution | |
| 8233 | In distribution | |
| S6900 | In distribution | |
| 5520 | In distribution | |
| 6500 | In distribution | |
| 4805 | In distribution | |
| 9400 | In distribution | |
| 0410 | In distribution | |
| USM6310 | In distribution | |
| USM6300 | In distribution | |
| 8102 | In distribution | |
| 9100 | In distribution | |
| 6002 | In distribution | |
| 962202 | In distribution | |
| 8121 | In distribution | |
| 960012 | In distribution | |
| 5500 | In distribution | |
| 788915 | In distribution | |
| 7300 | In distribution | |
| 8232 | In distribution | |
| 6810 | In distribution | |
| 7513 | In distribution | |
| 6900 | In distribution | |
| 5700 | In distribution | |
| S6400 | In distribution | |
| USM6910 | In distribution | |
| 6966 | In distribution | |
| 5522 | In distribution | |
| 5572BU | In distribution | |
| 8520 | In distribution | |
| 7121 | In distribution | |
| S5700 | In distribution | |
| 0110 | In distribution | |
| 5210 | In distribution | |
| 6362 | In distribution | |
| 2200 | In distribution | |
| 8231 | In distribution | |
| 126-MINDE-1.3A | In distribution | |
| S6200 | In distribution | |
| S6100 | In distribution | |
| 2400 | In distribution | |
| S6910 | In distribution | |
| 7889 | In distribution | |
| USM6400 | In distribution | |
| 7530 | In distribution | |
| 961502 | In distribution | |
| 6821 | In distribution | |
| 9082 | In distribution | |
| 7511 | In distribution | |
| 6300 | In distribution | |
| 7890 | In distribution | |
| 6366 | In distribution | |
| 7100 | In distribution | |
| 4451 | In distribution | |
| 7535 | In distribution | |
| 9510 | In distribution | |
| 8131 | In distribution | |
| 5571 | In distribution | |
| 8130 | In distribution | |
| 6820 | In distribution | |
| 5710S | In distribution | |
| 5450 | In distribution | |
| S6300 | In distribution | |
| 9610 | In distribution | |
| 990-002 | In distribution | |
| 6100 | In distribution | |
| 6805 | In distribution | |
| 5521 | In distribution | |
| 9081 | In distribution | |
| 6001 | In distribution | |
| 6086 | In distribution | |
| 5220 | In distribution | |
| 8141 | In distribution | |
| 6610 | In distribution | |
| 5435 | In distribution | |
| 990-102 | In distribution | |
| USM6900 | In distribution | |
| USM6500 | In distribution | |
| S6310 | In distribution | |
| 5501 | In distribution | |
| 1800 | In distribution | |
| 126-MINDE-1.3AD | In distribution | |
| 0420 | In distribution | |
| 6825 | In distribution | |
| 6700 | In distribution | |
| 7110 | In distribution | |
| 0120 | In distribution | |
| 7081 | In distribution | |
| USM6700 | In distribution | |
| 9500 | In distribution | |
| S6700 | In distribution | |
| 4810 | In distribution | |
| 7891 | In distribution | |
| 8230 | In distribution | |
| 5920 | In distribution | |
| 8522 | In distribution | |
| S6915 | In distribution | |
| 5710 | In distribution | |
| 5930 | In distribution | |
| 8123 | In distribution | |
| N6900 | In distribution | |
| 6360 | In distribution | |
| 6400 | In distribution | |
| 5591 | In distribution | |
| USM6945 | In distribution | |
| 6945 | In distribution | |
| 6984 | In distribution | |
| 7545 | In distribution | |
| 6962 | In distribution | |
| 6083 | In distribution | |
| 5910 | In distribution | |
| 5522BU | In distribution | |
| 8120 | In distribution | |
| 6320 | In distribution | |
| 8140 | In distribution | |
| 5520BU | In distribution | |
| 6961 | In distribution | |
| 5100 | In distribution | |
| S6960 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Swann Morton Ltd. | Swann Morton, Ltd. | 165 |
| Aesculap | Aesculap AG | 29 |
| Bard-Parker ® Safety Scalped | Aspen Surgical Products, Inc. | 19 |
| McKesson | Mckesson Medical-Surgical Inc. | 15 |
| Kiato Plus | Aditya Dispomed Products Private Ltd. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 15 |
| Sandel | Ansell Sandel Medical Solutions LLC | 14 |
| Sklar® | Sklar Corporation | 14 |
| Feather Disposable Scalpel | Feather Safety Razor Co., Ltd. | 14 |
| P&P Medical Surgical LLC | P&P Medical Surgical LLC | 14 |
| Bard-Parker ® Disposable Scalpels | Aspen Surgical Products, Inc. | 13 |
| Lumohs | Nano Surgical, Inc | 12 |
Showing 12 of 56. All products under Scalpel, One-Piece
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K923689 | 1992-09-09 |
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.