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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 1998 | K974327 | WINGED NEEDLE HOLDER Phx Technologies Corp. | FHQ |
| Jun 25, 1993 | K924196 | LAPAROSCOPIC NEEDLE HOLDER Nusurg, Inc. | FHQ |
| Jun 8, 1993 | K930330 | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION Holmed Corp. | FHQ |
| May 26, 1993 | K920706 | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES Retrax | FHQ |
| Jun 20, 1985 | K851780 | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS Artiberia | FHQ |
| Jun 20, 1985 | K851779 | 25-100,25-220 VARIOUS NEEDLE HOLDERS Artiberia | FHQ |
| Oct 4, 1977 | K771859 | NEEDLE HOLDER, MICROVASCULAR Edward Weck, Inc. | FHQ |
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