ZEE SURGICAL INSTRUMENTS
FDA 510(k) clearance K812814 · decided 1981-11-06
Clearance details
- K-number
- K812814
- Device name
- ZEE SURGICAL INSTRUMENTS
- Applicant
- Zee Medical Products Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-06
- Decision date
- 1981-11-06
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GDZ
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SPECTRA MEDICAL SAFETY SCAPEL (K091462) | Spectra, Inc. | 2009-12-15 |
| SCALPEL HANDLE (K890242) | Kinetic Medical Products | 1989-01-27 |
| BEAVER(R) HANDLE (K884512) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-11-17 |
| P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE (K863951) | Precision Surgical Industries, Inc. | 1986-10-24 |
| THE S. CORDERO STYLUS (K863808) | S. Cordero Co. | 1986-10-14 |
| KEISEI HANDLES FOR SURGICAL BLADES (K863212) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| SCALPEL HANDLE (K854858) | Medelec Intl. Corp. | 1985-12-24 |
| SCALPEL HANDLE #7 SS 410 OR 420 (K852735) | The Huxley Instrument Corp. | 1985-07-15 |
| SCALPEL HANDLE #3 SS 410 OR 420 (K852711) | The Huxley Instrument Corp. | 1985-07-15 |
| 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 (K851750) | Artiberia | 1985-06-20 |
| BRIMFIELD CANNULATED BLADE HOLDER (K852042) | Brimfield Scientific Instruments | 1985-06-11 |
| SURGICAL PAWS (K812876) | M-W Laboratories, Inc. | 1981-11-20 |
Recalls involving this device
No recalls on record reference this clearance.