GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
FDA 510(k) clearance K132375 · decided 2014-06-12
Clearance details
- K-number
- K132375
- Device name
- GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
- Applicant
- Genicon
- Decision
- Substantially Equivalent
- Date received
- 2013-07-30
- Decision date
- 2014-06-12
- Days to decision
- 317 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Winter Park, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The dev recall (Z-1642-2015) | DeRoyal Industries Inc | 2015-05-21 |