LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION
FDA 510(k) clearance K925903 · decided 1992-12-30
Clearance details
- K-number
- K925903
- Device name
- LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION
- Applicant
- Birtcher Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-12
- Decision date
- 1992-12-30
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABC PROBE REF 160656 5 mm Handswitching Probe, 28 cm QTY: 1 STERILE CONMED CORPORATION 525 recall (Z-2279-2010) | ConMed Electrosurgery | 2010-08-25 |
| ABC PROBE REF 160636 5 mm Handswitching Probe, 36 cm QTY: 1 STERILE CONMED CORPORATION 525 recall (Z-2280-2010) | ConMed Electrosurgery | 2010-08-25 |
| ABC PROBE REF 160644 5 mm Handswitching Probe, 44 cm QTY: 1 STERILE CONMED CORPORATION 525 recall (Z-2281-2010) | ConMed Electrosurgery | 2010-08-25 |
| ABC PROBE REF 160655 5 mm Footswitching Probe, QTY: 1 STERILE CONMED CORPORATION 525 Frenc recall (Z-2282-2010) | ConMed Electrosurgery | 2010-08-25 |