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Huck Towel

by South Mountain Medical

510(k) K852945

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852945 Date29 Jul 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.