Product code GAF
- Device name
- Spatula, Surgical, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- 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 |
|---|---|---|---|
| K023688 | LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER | LeMaitre Vascular, Inc. | 2003-01-30 |
| K935357 | SNAP RECIPROCATING SAW | Surgiquip, Inc. | 1994-01-28 |
| K890374 | ABDOMINAL SPATULA | Kinetic Medical Products | 1989-02-03 |
| K882793 | PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE | Pmt Corp. | 1988-07-18 |
| K822108 | CEMENT-PICK | Bio-Blitz, Inc. | 1982-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08961104622548 | Spatula 6mm Single Sided | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104622555 | Spatula 8.0 mm Single Sided | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08961104622562 | Spatula 10 mm Single Sided | MELPEX BEAUTY INSTRUMENTS | 2026-05-21 |
| 08800075627766 | OSUNG MND | OSUNG MND Co., Ltd. | 2025-11-03 |
| 07898506813209 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506813216 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506813223 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| 07898506845095 | Quinelato | Schobell Industrial Ltda | 2023-01-10 |
| ESAM4059161 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM4059131 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| 10649111170201 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111170119 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169984 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169854 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169717 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169540 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169403 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169267 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111169137 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111168918 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111168819 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111168666 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111168536 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111012471 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10649111012372 | Sklar | SKLAR CORPORATION | 2019-05-07 |
| 10381780165798 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-31 |
| 10381780426363 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-12 |
| 10381780426356 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-12 |
| 10381780426349 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-12 |
| 10381780425700 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-01-12 |