Cleared Traditional

K931144 - STERILE SURGEON'S GOWN

K931144 is an FDA 510(k) clearance for STERILE SURGEON'S GOWN, manufactured by Amsco Sterile Recoveries, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K931144 · Amsco Sterile Recoveries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
462d
Days
Class 2
Risk

K931144 is an FDA 510(k) clearance for the STERILE SURGEON'S GOWN, MODIFICATION. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Amsco Sterile Recoveries, Inc. devices

FDA 510(k) Submission Details - K931144

510(k) Number K931144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1993
Decision Date June 10, 1994
Days to Decision 462 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 129d · This submission: 462d
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 149
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K931144.
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · Baxter Healthcare Corp · Dec 1994
HYDRAGOWN
K934664 · Mallinckrodt Group, Inc. · May 1994
BARRIER FABRIC 450 SURGICAL GOWN
K934608 · Johnson & Johnson Medical, Inc. · Apr 1994
3M PREVENTION FABRIC SURGICAL GOWN #78XX
K930681 · 3M Health Care, Ltd. · Feb 1994