Holder, Needle, Gastroenterologic
FDA product code FHQ · Class I (low risk) · 21 CFR 876.4730 · Gastroenterology, Urology
7510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974327 | Winged Needle HolderFHQ · Traditional | Phx Technologies Corp. | 01/09/1998SE |
| K924196 | Laparoscopic Needle HolderFHQ · Traditional | Nusurg, Inc. | 06/25/1993SE |
| K930330 | Endoscopic Needleholder, ModificationFHQ · Traditional | Holmed Corp. | 06/08/1993SE |
| K920706 | Magnetic Point Guard for Surgical NeedlesFHQ · Traditional | Retrax | 05/26/1993SE |
| K851780 | 25-230 to 25-390 Various Needle HoldersFHQ · Traditional | Artiberia | 06/20/1985SE |
| K851779 | 25-100,25-220 Various Needle HoldersFHQ · Traditional | Artiberia | 06/20/1985SE |
| K771859 | Needle Holder, MicrovascularFHQ · Traditional | Edward Weck, Inc. | 10/04/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2767-2020 Class II | BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 -…The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the… | Boss Instruments, Ltd. | 06/26/2020Terminated |
| Z-2534-2020 Class II | DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle…Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the… | Dufner Instrumente GmbH | 06/03/2020Terminated |
| Z-2313-2017 Class II | Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide…COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do… | Cook Inc. | 05/01/2017Terminated |
| Z-1948-2009 | BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The…Product sterility may be compromised due to lack of package integrity. | Davol, Inc., Sub. C. R. Bard, Inc. | 07/30/2009Terminated |