FHQ — Holder, Needle, Gastroenterologic Class I
FDA product code FHQ covers "Holder, Needle, Gastroenterologic", a Class I medical device regulated under 21 CFR 876.4730. Submissions are reviewed by the Gastroenterology, Urology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- FHQ
- Device Class
- Class I
- Regulation Number
- 876.4730
- Submission Type
- 510(k) Exempt
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974327 | Phx Technologies | WINGED NEEDLE HOLDER | Jan 9, 1998 |
| K924196 | Nusurg | LAPAROSCOPIC NEEDLE HOLDER | Jun 25, 1993 |
| K930330 | Holmed | ENDOSCOPIC NEEDLEHOLDER, MODIFICATION | Jun 8, 1993 |
| K920706 | Retrax | MAGNETIC POINT GUARD FOR SURGICAL NEEDLES | May 26, 1993 |
| K851779 | Artiberia | 25-100,25-220 VARIOUS NEEDLE HOLDERS | Jun 20, 1985 |
| K851780 | Artiberia | 25-230 TO 25-390 VARIOUS NEEDLE HOLDERS | Jun 20, 1985 |
| K771859 | Edward Weck | NEEDLE HOLDER, MICROVASCULAR | Oct 4, 1977 |