ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
FDA 510(k) clearance K061555 · decided 2006-08-31
Clearance details
- K-number
- K061555
- Device name
- ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM
- Applicant
- Anchor Products Co.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-05
- Decision date
- 2006-08-31
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Addison, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 recall (Z-1590-2011) | Anchor Products Company, Inc. | 2011-03-07 |
| Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 recall (Z-1591-2011) | Anchor Products Company, Inc. | 2011-03-07 |