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 |
|---|---|---|---|
| 08961104621824 | Mathieu Standard Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621961 | Mathieu Hook Tip Grooved | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621954 | Mathieu Hole Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621947 | Mathieu Hole Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621930 | Mathieu Hook Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621923 | Mathieu Hook Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621916 | Mathieu Narrow Tip Half | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621909 | Mathieu Narrow Tip Half | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621893 | Mathieu Narrow Tip TC | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621886 | Mathieu Narrow Tip TC | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621879 | Mathieu Narrow Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621862 | Mathieu Narrow Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621855 | Mathieu Standard Tip TC | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621848 | Mathieu Standard Tip TC | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104621831 | Mathieu Standard Tip | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| G149TBSB7400 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7390 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7380 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7370 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G45313110753150 | PEAK MEDICAL | Peak Medical Distribution Inc. | 2026-05-06 |
| G4254209140 | My Medical | My Medical Store LLC | 2026-05-04 |
| G4254209120 | My Medical | My Medical Store LLC | 2026-05-04 |
| G4254203160 | My Medical | My Medical Store LLC | 2026-05-04 |
| G4254202900 | My Medical | My Medical Store LLC | 2026-05-04 |
| G4254209170 | My Medical | My Medical Store LLC | 2026-02-17 |
| G45313110845130 | PEAK MEDICAL | Peak Medical Distribution Inc. | 2023-07-03 |
| G25004025180 | Tungsten Carbide Debakey Needle Holder 18cm | N S SURGICAL COMPANY | 2023-01-27 |
| G390MM6000570 | Needle Holder TC | NTZ SURGICAL COMPANY | 2022-12-30 |
| G390MM4000010 | Needle Holder | NTZ SURGICAL COMPANY | 2022-12-10 |
| 08714729753070 | Capio | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |