Patient Safe® 52001
by Retractable Technologies, Inc.
Patient Safe® 52001 is a Class II device made by Retractable Technologies, Inc., cleared under FDA 510(k) K072654 on 14 Dec 2007 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00613703520005), 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 | Number00613703520005 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k) | NumberK072654 | Date14 Dec 2007 | StatusActive |
Official records
- AccessGUDID record 00613703520005
- FDA 510(k) database K072654
Across registries
- FDA 510(k) K072654 decided 14 Dec 2007 Active
- FDA GUDID UDI-DI 00613703520005 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K072654
- Listed FDA GUDID 00613703520005
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Patient Safe®
- Generic name
- General-purpose syringe, single-use
- Model / Ref / Catalog
- 52001
- Primary DI / UDI-DI
- 00613703520005
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- General-purpose syringe, single-use
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose syringe, single-use.