Huck Towel
510(k) K852945
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852945 | Date29 Jul 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 19 Sep 2026
The Huck Towel is a surgical towel (Product Code: KKX), designed as a disposable, absorbent textile used in medical settings for cleaning, wiping, or draping purposes. Constructed from 100% cotton, it is hemmed on all four sides to prevent fraying and ensure reliability during use.
Supplied in sterile packs, the Huck Towel is intended for single-use in surgical, medical, or janitorial environments. It is classified under the General, Plastic Surgery advisory committee and holds an FDA 510(k) clearance (K852945) as substantially equivalent to a predicate device, dated July 29, 1985. Available in multiple colors (Blue, Green, Teal), it is manufactured by South Mountain Medical and distributed for sterile use.
Other devices from South Mountain Medical
Questions
AI-generated answers, 19 Sep 2026
What are the primary uses for the Huck Towel in a medical setting?
The Huck Towel is designed for cleaning, wiping, or draping in surgical, medical, or janitorial environments. Its absorbent cotton construction makes it ideal for tasks requiring moisture absorption, such as prepping surfaces or maintaining sterile fields during procedures.
Is the Huck Towel reusable, or is it meant for single-use only?
The Huck Towel is explicitly labeled for single-use only, even though it is constructed from durable 100% cotton. This ensures hygiene and prevents cross-contamination in sterile environments.
How is the Huck Towel supplied, and is it sterile?
The Huck Towel comes in sterile packs, ready for immediate use in medical or surgical settings. Sterility is maintained to meet clinical requirements for cleanliness and infection control.
What colors are available for the Huck Towel, and does the color affect functionality?
The Huck Towel is available in Blue, Green, and Teal colors. The color variation does not impact its absorbent or sterile properties but may help with workflow organization or color-coding in operating rooms.
How was the Huck Towel’s regulatory clearance determined, and what does that mean for buyers?
The Huck Towel received FDA 510(k) clearance (K852945) under the Traditional review pathway, classified as *substantially equivalent* to a predicate device. This means it meets FDA standards for safety and effectiveness as a disposable surgical towel (Product Code: KKX) and is approved for use in medical settings.