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Multiple Sterile Surgical Drape Pack

by Assured Surgical Products, Inc. 510(k)

Active United States

510(k) K914605

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK914605 Date15 Jan 1992ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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
SESK Substantially Equivalent — Kit

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.

This device is a sterile surgical drape pack designed to maintain a sterile field during surgical procedures. It consists of multiple drapes intended to cover the patient, surgical instruments, and surrounding areas to prevent contamination and infection.

The pack is supplied sterile and intended for single-use in operating rooms and surgical settings. Authorized under FDA 510(k) clearance (K914605), it adheres to infection control standards and is classified under product code KKX. No additional reprocessing or sterilization is required before use.

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