LAPAROSCOPIC RETRACTORS
FDA 510(k) clearance K092684 · decided 2010-01-22
Clearance details
- K-number
- K092684
- Device name
- LAPAROSCOPIC RETRACTORS
- Applicant
- Cardinal Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-01
- Decision date
- 2010-01-22
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 8789 recall (Z-2212-2016) | Carefusion 2200 Inc | 2016-07-22 |