#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES
FDA 510(k) clearance K885199 · decided 1989-01-13
Clearance details
- K-number
- K885199
- Device name
- #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES
- Applicant
- Olsen Electrosurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-16
- Decision date
- 1989-01-13
- Days to decision
- 28 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
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reu recall (Z-1994-2012) | PSC Industries Inc | 2012-07-12 |
| Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, M recall (Z-1997-2012) | PSC Industries Inc | 2012-07-12 |
| Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bi recall (Z-1998-2012) | PSC Industries Inc | 2012-07-12 |
| Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irrigating Bipola recall (Z-1999-2012) | PSC Industries Inc | 2012-07-12 |