Panels › Gastroenterology, Urology › Product code FHQ · Class 1
Holder, Needle, Gastroenterologic
Regulation 876.4730
0510(k)s in 12 months (7 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in FHQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Artiberia | 2 | 0 |
| Boss Instruments, Ltd. | 0 | 1 |
| Cook Inc. | 0 | 1 |
| Davol, Inc., Sub. C. R. Bard, Inc. | 0 | 1 |
| Dufner Instrumente GmbH | 0 | 1 |
| Edward Weck, Inc. | 1 | 0 |
| Holmed Corp. | 1 | 0 |
| Nusurg, Inc. | 1 | 0 |
| Phx Technologies Corp. | 1 | 0 |
| Retrax | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2020 | Boss Instruments, Ltd. BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes Terminated |
FHQ | None listed |
| Jun 3, 2020 | Dufner Instrumente GmbH DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures
Reference Number: 18044-23 Terminated |
FHQ | None listed |
| May 1, 2017 | Cook Inc. Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages.
Used for internal suturing under direct vision during intraabdominal endoscopic pro Terminated |
FHQ | None listed |
| Sep 6, 2009 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Simpulse" SOLO System with Soft Splash Shield Tip
Product Code: 0067590.
The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and gene Terminated |
FHQ | None listed |
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