FKN — Adaptor, Shunt Class II
FDA product code FKN covers "Adaptor, Shunt", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKN
- Device Class
- Class II
- Regulation Number
- 876.5540
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K893478 | akcess medical products | DA-16 AND DA-24 SHUNT ADAPTERS | June 8, 1989 |
| K892667 | akcess medical products | SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 | May 4, 1989 |
| K813428 | quinton | SHUNT ADAPTER | December 31, 1981 |
| K771425 | quinton | A-V SHUNT EXTENSION | January 3, 1978 |