Scalpel Handle
FDA 510(k) K854858 · Medelec Intl. Corp.
510(k) numberK854858
Submission
- Device name
- Scalpel Handle
- Applicant
- Medelec Intl. Corp.
Miami Beach, FL, US - Received
- December 5, 1985
- Decision date
- December 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDZ – Handle, Scalpel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091462 | Spectra Medical Safety ScapelGDZ · Traditional | Spectra, Inc. | 12/15/2009SE |
| K890242 | Scalpel HandleGDZ · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K884512 | Beaver(R) HandleGDZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/17/1988SE |
| K863951 | P.S.I.-Disposable Scalpel Surgeons HandleGDZ · Traditional | Precision Surgical Industries, Inc. | 10/24/1986SE |
| K863808 | The S. Cordero StylusGDZ · Traditional | S. Cordero Co. | 10/14/1986SE |
| K863212 | Keisei Handles for Surgical BladesGDZ · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
| K852735 | Scalpel Handle #7 SS 410 or 420GDZ · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852711 | Scalpel Handle #3 SS 410 or 420GDZ · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K851750 | 7-103, 7-104, 7-107 Scalpel Handles, #3 #4 #7GDZ · Traditional | Artiberia | 06/20/1985SE |
| K852042 | Brimfield Cannulated Blade HolderGDZ · Traditional | Brimfield Scientific Instruments | 06/11/1985SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K961013 | Disposable Needle ElectrodeIKT · Traditional | 12/20/1996SE |
| K935017 | TD50 ElectromyographJXE · Traditional | 07/28/1994SE |
| K922548 | Medelec 2110 and 2114 EEGGWQ · Traditional | 11/03/1992SE |
| K920127 | Electroencephalograph Recording SystemGWQ · Traditional | 06/10/1992SE |
| K912775 | Sapphire 4ME Emg/Ep SystemGWF · Traditional | 11/08/1991SE |
| K865106 | Prophylactic (Condom) Mr. JohnnyHIS · Traditional | 05/20/1987SE |
| K863491 | Blood Specimen Collection DevicesJKA · Traditional | 10/24/1986SE |
| K854622 | Prophylactic (Condom)HIS · Traditional | 04/11/1986SE |
| K854562 | Connector, Blood Tubing, Infusion T. Intravenous IBRZ · Traditional | 01/09/1986SE |
| K854860 | Blades, Scalpel Carbon SteetGES · Traditional | 12/24/1985SE |
Questions and answers
When was Scalpel Handle cleared by the FDA?
Scalpel Handle (K854858) received a 510(k) decision of Substantially Equivalent on December 24, 1985, 19 days after the submission was received.
What is the product code of K854858?
The FDA product code is GDZ – Handle, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.