ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
FDA 510(k) clearance K010007 · decided 2001-02-22
Clearance details
- K-number
- K010007
- Device name
- ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
- Applicant
- Taut, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-02
- Decision date
- 2001-02-22
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Geneva, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universa recall (Z-1326-2014) | Teleflex Medical | 2014-04-02 |
| 5/10 mm Weck, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and recall (Z-1279-2014) | Teleflex Medical | 2014-03-25 |
| 5/10/12 mm Weck Vista" Universal Cannula, Product Usage: An endoscope and accessories is a recall (Z-1284-2014) | Teleflex Medical | 2014-03-25 |