Accu-Beam 1105
by Transamerican Technologies International
Accu-Beam 1105 is a laser adaptor (FDA Class II; FDA product code HHR, Laser, Surgical, Gynecologic) made by Transamerican Technologies International, cleared under FDA 510(k) K864378 on 5 Mar 1987 and listed in FDA GUDID since 24 Sep 2018 (UDI-DI B17711050), 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 | NumberB17711050 | Date24 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK864378 | Date5 Mar 1987 | StatusActive |
Official records
- FDA 510(k) database K864378
Across registries
- FDA 510(k) K864378 decided 5 Mar 1987 Active
- FDA GUDID UDI-DI B17711050 listed 24 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K864378
- Listed FDA GUDID B17711050
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Accu-Beam
- Generic name
- Laser adaptor
- Model / reference
- 1105
- Primary DI / UDI-DI
- B17711050
- 510(k) Number
- FDA product code
- HHR
- GMDN term
- Laser adaptor
- Device class
- Class II
- Regulation number
- 884.4550
- GUDID distribution status
- In Commercial Distribution
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