Surgical Drape (KKX)
510(k) K910084
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910084 | Date19 Mar 1991 | 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- Withdrawn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
- Full name
- Surgical Drape
- 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
This device is a surgical drape (Product Code: KKX), classified as a protective patient covering intended to isolate surgical sites from microbial and environmental contamination. Constructed from natural or synthetic materials, it serves as a barrier to prevent cross-contamination during procedures, ensuring a sterile field around incisions or wounds. The drape may include adhesive wound protectors designed to secure placement or cover exposed wound edges, enhancing surgical site integrity.
The Surgical Drape (KKX) is supplied as a single-use item for use in operating rooms, surgical suites, or procedural settings where sterile field maintenance is critical. It is not specified as MRI-safe or reusable; sterility is ensured through manufacturer packaging. No additional regulatory details beyond its FDA 510(k) clearance (K910084) are provided in the data, and no size specifications are listed. Compliance with FDA Substantial Equivalence (SESE) standards applies, as determined by the Surgical and Urological Devices (SU) Advisory Committee.
Other devices from Biocor Medical, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of this surgical drape, and where is it typically used?
This surgical drape is designed as a protective patient covering to create a sterile barrier around surgical sites, preventing microbial and environmental contamination. It is intended for use in operating rooms, surgical suites, or procedural settings where maintaining a sterile field is essential during procedures like incisions or wound care.
Is this drape meant for single-use or can it be reused after sterilization?
The drape is explicitly supplied as a single-use item, meaning it is not intended for reuse even after sterilization. Its sterility is ensured through manufacturer packaging, and reuse could compromise the sterile field and patient safety.
Does this product include any additional features, such as adhesive wound protectors?
Yes, this surgical drape may include adhesive wound protectors as part of its design. These features help secure the drape in place and cover exposed wound edges, improving surgical site integrity and reducing the risk of contamination.
How was the regulatory clearance for this device determined, and which advisory committee was involved?
The device received FDA 510(k) clearance (K910084) under the Substantial Equivalence (SESE) standard, meaning it was deemed equivalent to a legally marketed predicate device. The Surgical and Urological Devices (SU) Advisory Committee reviewed it, specifically under the General, Plastic Surgery category, before clearance.
What should I consider when storing this drape to maintain its integrity?
Since this drape is single-use and relies on manufacturer packaging for sterility, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise its sterility before use.