LacriCATH DCR508-BIT
LacriCATH DCR508-BIT is a device classified as Unclassified made by Quest Medical Inc, cleared under FDA 510(k) K113867 on 19 Oct 2012 and listed in FDA GUDID since 18 May 2016 (UDI-DI 20634624438525), 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 | Number20634624438525 | Date18 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113867 | Date19 Oct 2012 | StatusActive |
Official records
- AccessGUDID record 20634624438525
- FDA 510(k) database K113867
Across registries
- FDA 510(k) K113867 decided 19 Oct 2012 Active
- FDA GUDID UDI-DI 20634624438525 listed 18 May 2016 Listed
Timeline
- Cleared FDA 510(k) K113867
- Listed FDA GUDID 20634624438525
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LacriCATH
- Generic name
- Lacrimal intubation set
- Model / reference
- DCR508-BIT
- Primary DI / UDI-DI
- 20634624438525
- 510(k) Number
- FDA product code
- OKS
- GMDN term
- Lacrimal intubation set
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code OKS (Lacrimal Stents And Intubation Sets).
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- ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET by Atrion Medical Products, Inc.
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