WECK REUSABLE OBTURATOR
FDA 510(k) clearance K121796 · decided 2012-10-11
Clearance details
- K-number
- K121796
- Device name
- WECK REUSABLE OBTURATOR
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-19
- Decision date
- 2012-10-11
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog N recall (Z-1324-2014) | Teleflex Medical | 2014-04-02 |
| 10mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessori recall (Z-1277-2014) | Teleflex Medical | 2014-03-25 |
| 12mm Weck Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessori recall (Z-1282-2014) | Teleflex Medical | 2014-03-25 |