Product code GDZ
- Device name
- Handle, Scalpel
- 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 |
|---|---|---|---|
| K091462 | SPECTRA MEDICAL SAFETY SCAPEL | Spectra, Inc. | 2009-12-15 |
| K890242 | SCALPEL HANDLE | Kinetic Medical Products | 1989-01-27 |
| K884512 | BEAVER(R) HANDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-11-17 |
| K863951 | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE | Precision Surgical Industries, Inc. | 1986-10-24 |
| K863808 | THE S. CORDERO STYLUS | S. Cordero Co. | 1986-10-14 |
| K863212 | KEISEI HANDLES FOR SURGICAL BLADES | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K854858 | SCALPEL HANDLE | Medelec Intl. Corp. | 1985-12-24 |
| K852711 | SCALPEL HANDLE #3 SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-15 |
| K852735 | SCALPEL HANDLE #7 SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-15 |
| K851750 | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 | Artiberia | 1985-06-20 |
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Brimfield Scientific Instruments | 1985-06-11 |
| K812876 | SURGICAL PAWS | M-W Laboratories, Inc. | 1981-11-20 |
| K812814 | ZEE SURGICAL INSTRUMENTS | Zee Medical Products Co., Inc. | 1981-11-06 |
| K812070 | BORES* ADJUSTABLE BLADE HOLDER | Santa Barbara Medco, Inc. | 1981-08-18 |
| K810720 | I.M. SCALPEL HANDLE | Instrument Makar, Inc. | 1981-04-03 |
| K761035 | SURGICAL BLADE HANDLES | Parke-Davis Co. | 1976-12-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00724995314699 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995314705 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995314712 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995314729 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995317362 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995317379 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995320492 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995320508 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995320515 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995320522 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995320539 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995343446 | V. Mueller | Steris Corporation | 2026-08-21 |
| 00724995314682 | V. Mueller | Steris Corporation | 2026-08-21 |
| 04054462913480 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913527 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913473 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 04054462913466 | evonos | evonos GmbH & Co. KG | 2026-08-19 |
| 00190776422837 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 07613327651188 | VersiQuad | STRYKER CORPORATION | 2026-07-22 |
| 00190776396800 | Millennium | Avalign Technologies, Inc. | 2026-07-14 |
| 00810055255689 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255696 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255702 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255726 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255788 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255801 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255825 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055255863 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00810055256105 | Surgical Design | Surgical Design, Inc. | 2026-06-26 |
| 00190776421847 | Millennium | Avalign Technologies, Inc. | 2026-06-25 |