Beaver(R) Handle
FDA 510(k) K884512 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK884512
Submission
- Device name
- Beaver(R) Handle
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- October 27, 1988
- Decision date
- November 17, 1988
- 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
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|---|---|---|---|
| K091462 | Spectra Medical Safety ScapelGDZ · Traditional | Spectra, Inc. | 12/15/2009SE |
| K890242 | Scalpel HandleGDZ · Traditional | Kinetic Medical Products | 01/27/1989SE |
| 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 |
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Questions and answers
When was Beaver(R) Handle cleared by the FDA?
Beaver(R) Handle (K884512) received a 510(k) decision of Substantially Equivalent on November 17, 1988, 21 days after the submission was received.
What is the product code of K884512?
The FDA product code is GDZ – Handle, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.