ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
FDA 510(k) clearance K082156 · decided 2008-09-10
Clearance details
- K-number
- K082156
- Device name
- ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
- Applicant
- Teleflex Medical
- Decision
- Substantially Equivalent
- Date received
- 2008-07-30
- Decision date
- 2008-09-10
- Days to decision
- 42 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
+ Add to Predicate Builder ◉ Watch Teleflex Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vist recall (Z-1323-2014) | Teleflex Medical | 2014-04-02 |
| Weck Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope a recall (Z-1276-2014) | Teleflex Medical | 2014-03-25 |
| Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope recall (Z-1280-2014) | Teleflex Medical | 2014-03-25 |
| Weck Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope recall (Z-1281-2014) | Teleflex Medical | 2014-03-25 |
| TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Steri recall (Z-1890-2010) | Teleflex Medical | 2010-06-23 |