Cleared Traditional

K961239 - DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL

K961239 is an FDA 510(k) clearance for DEPUY STERILE VIEW BARRIER HOOD/GOWN WI..., manufactured by Depuy, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K961239 · Depuy, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
169d
Days
Class 2
Risk

K961239 is an FDA 510(k) clearance for the DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Depuy, Inc. (Dayton, US). The FDA issued a Cleared decision on September 17, 1996 after a review of 169 days - an extended review cycle.

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 Depuy, Inc. devices

FDA 510(k) Submission Details - K961239

510(k) Number K961239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date September 17, 1996
Days to Decision 169 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
40d slower than avg
Panel avg: 129d · This submission: 169d
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 225
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K961239.
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OREX SURGEON'S VEST
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K960073 · Safetec of America, Inc. · Jul 1996