Scalpel Handle
FDA 510(k) K890242 · Kinetic Medical Products
510(k) numberK890242
Submission
- Device name
- Scalpel Handle
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 18, 1989
- Decision date
- January 27, 1989
- 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 |
| 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 |
| K854858 | Scalpel HandleGDZ · Traditional | Medelec Intl. Corp. | 12/24/1985SE |
| 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 |
More from Brimfield Scientific Instruments
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
Questions and answers
When was Scalpel Handle cleared by the FDA?
Scalpel Handle (K890242) received a 510(k) decision of Substantially Equivalent on January 27, 1989, 9 days after the submission was received.
What is the product code of K890242?
The FDA product code is GDZ – Handle, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.