Cleared Traditional

K945658 - INTERWOVEN(TM) REUSABLE SURGICAL GOWN

K945658 is an FDA 510(k) clearance for INTERWOVEN(TM) REUSABLE SURGICAL GOWN, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K945658 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
125d
Days
Class 2
Risk

K945658 is an FDA 510(k) clearance for the INTERWOVEN(TM) REUSABLE SURGICAL GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K945658

510(k) Number K945658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date March 22, 1995
Days to Decision 125 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 129d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 226
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K945658.
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS
K945371 · Standard Textile Co., Inc. · Apr 1995
PERVAL SURGICAL GOWN (MARKETING NAME)
K950504 · Standard Textile Co., Inc. · Apr 1995
OREX SURGEON'S GOWN
K944827 · Thantex Specialties, Inc. · Feb 1995
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · Baxter Healthcare Corp · Dec 1994
HYDRAGOWN
K934664 · Mallinckrodt Group, Inc. · May 1994