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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00724995286248 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995286286 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995320164 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995320263 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995320317 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995320324 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995320331 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995320348 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00724995279622 | V. Mueller | STERIS Deutschland GmbH | 2026-09-25 |
| 00840319759424 | Hayden Medical | Hayden Medical, Inc. | 2026-09-04 |
| 00190776419684 | Millennium | Avalign Technologies, Inc. | 2026-08-25 |
| B382SD45267180 | Surgical Direct | Surgical Direct, Inc. | 2026-08-03 |
| 00850083997007 | Suture Sheild | SUTURE SHIELD, INC. | 2026-08-03 |
| B382SD90557818E0 | Surgical Direct | Surgical Direct, Inc. | 2026-07-29 |
| 00810143905076 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143905083 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143905106 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143907193 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143908671 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143908701 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143909081 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143909753 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810143909760 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810212931517 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810212931678 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810212934709 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810212934716 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| 00810212934723 | SURGIPROS | Surgipros, LLC | 2026-07-28 |
| B382SD905500140 | Surgical Direct | Surgical Direct, Inc. | 2022-11-30 |
| 00840329808914 | N/A | BLACK & BLACK SURGICAL, INC. | 2022-09-21 |