Bi-Blade® 2360BB
by Medical Instrument Development Laboratories, Inc.
Bi-Blade 2360BB is a vitrectomy system micro-cutting unit (FDA Class II; FDA product code HQE, Instrument, Vitreous Aspiration And Cutting, Ac-Powered) made by Medical Instrument Development Laboratories, Inc., cleared under FDA 510(k) K153168 on 29 Apr 2016 and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 00812480010765), active as of 22 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 | Number00812480010765 | Date24 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153168 | Date29 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 00812480010765
- FDA 510(k) database K153168
Across registries
- FDA 510(k) K153168 decided 29 Apr 2016 Active
- FDA GUDID UDI-DI 00812480010765 listed 24 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K153168
- Listed FDA GUDID 00812480010765
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bi-Blade®
- Generic name
- Vitrectomy system micro-cutting unit
- Model / Ref / Catalog
- 2360BB
- Primary DI / UDI-DI
- 00812480010765
- 510(k) Number
- FDA product code
- HQE
- GMDN term
- Vitrectomy system micro-cutting unit
- Device class
- Class II
- Regulation number
- 886.4150
- GUDID distribution status
- In Commercial Distribution
- Size
- Needle Gauge — 27 Gauge
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