WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
FDA 510(k) clearance K121380 · decided 2012-05-25
Clearance details
- K-number
- K121380
- Device name
- WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
- Applicant
- Teleflexmedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-05-08
- Decision date
- 2012-05-25
- Days to decision
- 17 days
- Clearance type
- Special
- 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 |
|---|---|---|
| 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/1 recall (Z-1325-2014) | Teleflex Medical | 2014-04-02 |
| 5/10 mm Weck, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endosco recall (Z-1278-2014) | Teleflex Medical | 2014-03-25 |
| 5/10/12 mm Weck Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endos recall (Z-1283-2014) | Teleflex Medical | 2014-03-25 |