Sure Comfort 22-6505
Sure Comfort 22-6505 is a Class II device made by Allison Medical, Inc., cleared under FDA 510(k) K152879 on 9 Sep 2016 and listed in FDA GUDID since 3 Nov 2016 (UDI-DI 00786227650555), 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 | Number00786227650555 | Date3 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152879 | Date9 Sep 2016 | StatusActive |
Official records
- AccessGUDID record 00786227650555
- FDA 510(k) database K152879
Across registries
- FDA 510(k) K152879 decided 9 Sep 2016 Active
- FDA GUDID UDI-DI 00786227650555 listed 3 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K152879
- Listed FDA GUDID 00786227650555
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sure Comfort
- Generic name
- Insulin syringe/needle, basic
- Model / Ref / Catalog
- 22-6505
- Primary DI / UDI-DI
- 00786227650555
- 510(k) Number
- FDA product code
- FMF
- GMDN term
- Insulin syringe/needle, basic
- Device class
- Class II
- Regulation number
- 880.5860
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 0.5 MilliliterLength — 8 MillimeterNeedle Gauge — 31 Gauge
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