Maxon 8886 6015-63
by Covidien LP
Maxon 8886 6015-63 is a Class II device made by Covidien LP, cleared under FDA 510(k) K990951 on 1 Apr 1999 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 10884521140851), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521140851 | Date30 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK990951 | Date1 Apr 1999 | StatusActive |
Official records
- AccessGUDID record 10884521140851
- FDA 510(k) database K990951
Across registries
- FDA 510(k) K990951 decided 1 Apr 1999 Active
- FDA GUDID UDI-DI 10884521140851 listed 30 Aug 2015 Listed
Recalls
-
- Terminated Z-2542-2017
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Timeline
- Cleared FDA 510(k) K990951
- Listed FDA GUDID 10884521140851
- Recall initiated FDA recalls Z-2542-2017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Maxon
- Generic name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Model / reference
- 8886 6015-63
- Primary DI / UDI-DI
- 10884521140851
- 510(k) Number
- FDA product code
- GAM
- GMDN term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.4493
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 18 Inch
Similar devices in this category
Other devices filed under Polyester suture, bioabsorbable, monofilament, non-antimicrobial.