PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
FDA 510(k) clearance K813335 · decided 1982-01-08
Clearance details
- K-number
- K813335
- Device name
- PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY
- Applicant
- American Pharmaseal Div. Ahsc
- Decision
- Substantially Equivalent
- Date received
- 1981-11-24
- Decision date
- 1982-01-08
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- FSH
- 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 |
|---|---|---|
| S 4 INSTRUMENT STAND (K884876) | Carl Zeiss, Inc. | 1988-12-15 |
| S 21 INSTRUMENT STAND (K883578) | Carl Zeiss, Inc. | 1988-09-13 |
| STAND, SURG. INSTRUMENT & DRESSING (K821921) | Emerson-Sack-Warner Corp. | 1982-07-30 |
| SKINNY CHIBA NEEDLE & TRAY (K813337) | American Pharmaseal Div. Ahsc | 1982-01-28 |
| BIOPSY NEEDLES & TRAYS (K813338) | American Pharmaseal Div. Ahsc | 1982-01-28 |
| MODEL 902 STAND (K780759) | Applied Medical Research | 1978-05-19 |
| FSH RIA KIT (125I) (K772188) | Diagnostic Products Corp. | 1977-12-22 |
Recalls involving this device
No recalls on record reference this clearance.