TEW BYPASS INSTRUMENTS & DISSECTING KIT
FDA 510(k) clearance K791703 · decided 1979-10-04
Clearance details
- K-number
- K791703
- Device name
- TEW BYPASS INSTRUMENTS & DISSECTING KIT
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-08-28
- Decision date
- 1979-10-04
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- GDI
- 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 |
|---|---|---|
| DISPOSABLE EXTERNAL CLAMPS (K896383) | Galenica Enterprises, Inc. | 1989-12-06 |
| HEPATIC PARENCHYMAL SUCTION DISSECTOR (K850288) | Beecher Medical Diagnostic Instrumentation | 1985-03-18 |
| ROUND-BEEHIVE- DISSECTORS 3/8 (K831912) | Ormed Mfg., Inc. | 1983-10-31 |
| TYMPANOPLASTY & SKIN DISSECTORS (K822569) | Kelleher Corp. | 1982-10-06 |
| FIELD SUCTION DISSECTOR (K803292) | V. Mueller O.V. Baxter Healthcare Corp. | 1981-01-29 |
| DISPOSABLE SPECIALITY SPONGES (K791870) | Carwild Corp. | 1979-11-05 |
Recalls involving this device
No recalls on record reference this clearance.