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 |
|---|---|---|---|
| 09348811000040 | INKA | The Trustee for KAISER FAMILY TRUST | 2025-11-19 |
| G25001001030 | Scalpel Handle No.3 | N S SURGICAL COMPANY | 2023-01-31 |
| G25001002040 | Scalpel Handle No.4 | N S SURGICAL COMPANY | 2023-01-31 |
| 07708626670395 | SAMPEDRO | INDUSTRIAS MEDICAS SAMPEDRO S A S | 2023-01-18 |
| 10080196652518 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-01-01 |
| 10080196652532 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-01-01 |
| 10080196652549 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2022-01-01 |
| 10381780165378 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780167174 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780167167 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780165965 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780165507 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780165453 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780025313 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193326 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193319 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193265 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193258 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193241 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193234 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780193227 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780192794 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025245 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025252 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025269 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025276 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025283 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025290 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780025306 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-02 |
| 10381780167662 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |