SPECIMEN RETRIEVAL SYSTEM
FDA 510(k) clearance K060051 · decided 2006-01-19
Clearance details
- K-number
- K060051
- Device name
- SPECIMEN RETRIEVAL SYSTEM
- Applicant
- Applied Medical Resources Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-06
- Decision date
- 2006-01-19
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Rancho Santa, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Mod recall (Z-0183-2014) | Applied Medical Resources Corp | 2014-01-24 |