Scalpel Handle #3 SS 410 or 420
FDA 510(k) K852711 · The Huxley Instrument Corp.
510(k) numberK852711
Submission
- Device name
- Scalpel Handle #3 SS 410 or 420
- Applicant
- The Huxley Instrument Corp.
Penn Yan, NY, US - Received
- June 26, 1985
- Decision date
- July 15, 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 |
| 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 |
| 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 |
|---|---|---|
| K852721 | Bozeman Uterine Forceps, Straight, 10+410 0R 420HCZ · Traditional | 09/06/1985SE |
| K853016 | Stille Angular Rongeur, 8-3/4 SS 410 · Traditional | 08/07/1985SE |
| K852993 | Bone Rongeurs · Traditional | 08/07/1985SE |
| K853015 | Self-Centering Bone Holding Forceps, 10-1/4 SS420GEN · Traditional | 07/29/1985SE |
| K852716 | Taylor Percussion Hammer SS 410 or 420GWZ · Traditional | 07/26/1985SE |
| K852735 | Scalpel Handle #7 SS 410 or 420GDZ · Traditional | 07/15/1985SE |
| K852734 | O.R. Scissors, Straight, 5-1/2+SHP/SHP SS · Traditional | 07/15/1985SE |
| K852732 | Iris Scissors, Curved, 4-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852731 | Lister Bandage Scissors, 5-1/2+SS 410 or 420 · Traditional | 07/15/1985SE |
| K852730 | Crile Forceps, Striaght, 6-1/4+SS 410 or 420GEN · Traditional | 07/15/1985SE |
Questions and answers
When was Scalpel Handle #3 SS 410 or 420 cleared by the FDA?
Scalpel Handle #3 SS 410 or 420 (K852711) received a 510(k) decision of Substantially Equivalent on July 15, 1985, 19 days after the submission was received.
What is the product code of K852711?
The FDA product code is GDZ – Handle, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.