AincA® 00-107-P
by Anesthesia Associates, Inc.
AincA® 00-107-P is a Class II device made by Anesthesia Associates, Inc., cleared under FDA 510(k) K811614 on 18 Jun 1981 and listed in FDA GUDID since 31 Mar 2021 (UDI-DI B00500107P0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB00500107P0 | Date31 Mar 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK811614 | Date18 Jun 1981 | StatusActive |
Official records
- FDA 510(k) database K811614
Across registries
- FDA 510(k) K811614 decided 18 Jun 1981 Active
- FDA GUDID UDI-DI B00500107P0 listed 31 Mar 2021 Listed
Timeline
- Cleared FDA 510(k) K811614
- Listed FDA GUDID B00500107P0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AincA®
- Generic name
- Block-monitoring peripheral nerve electrical stimulation system
- Model / Ref / Catalog
- 00-107-P
- Primary DI / UDI-DI
- B00500107P0
- 510(k) Number
- FDA product code
- BXN
- GMDN term
- Block-monitoring peripheral nerve electrical stimulation system
- Device class
- Class II
- Regulation number
- 868.2775
- GUDID distribution status
- In Commercial Distribution
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