OLYMPUS OES LAPAROSCOPY SYSTEM
FDA 510(k) clearance K923982 · decided 1993-03-15
Clearance details
- K-number
- K923982
- Device name
- OLYMPUS OES LAPAROSCOPY SYSTEM
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-07
- Decision date
- 1993-03-15
- Days to decision
- 220 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in recall (Z-1163-2010) | Olympus America Inc. | 2010-03-18 |