ADAPT OPEN ACCESS PORT, MODEL 41233
FDA 510(k) clearance K021731 · decided 2002-08-08
Clearance details
- K-number
- K021731
- Device name
- ADAPT OPEN ACCESS PORT, MODEL 41233
- Applicant
- Taut, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-24
- Decision date
- 2002-08-08
- Days to decision
- 76 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 |
|---|---|---|
| 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope recall (Z-1327-2014) | Teleflex Medical | 2014-04-02 |
| 5/10/12MM X 100MM Weck Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and recall (Z-1285-2014) | Teleflex Medical | 2014-03-25 |