Product code FHQ
- Device name
- Holder, Needle, Gastroenterologic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.4730
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974327 | WINGED NEEDLE HOLDER | Phx Technologies Corp. | 1998-01-09 |
| K924196 | LAPAROSCOPIC NEEDLE HOLDER | Nusurg, Inc. | 1993-06-25 |
| K930330 | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION | Holmed Corp. | 1993-06-08 |
| K920706 | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES | Retrax | 1993-05-26 |
| K851779 | 25-100,25-220 VARIOUS NEEDLE HOLDERS | Artiberia | 1985-06-20 |
| K851780 | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS | Artiberia | 1985-06-20 |
| K771859 | NEEDLE HOLDER, MICROVASCULAR | Edward Weck, Inc. | 1977-10-04 |
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