Linen (Huck) Towel
by Dimed, Intl. 510(k)
Active
510(k) K862577
Overview
The LINEN (HUCK) TOWEL is a widely used, FDA-substantially equivalent medical device designed to provide enhanced drape stability during surgical procedures. By utilizing a unique antimicrobial coating and ergonomic design, this towel enhances the safety and efficiency of surgical outcomes.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862577 | Date23 Jul 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent