Cleared Traditional

K972832 - PROVISION SURGICAL HELMET SYSTEM

K972832 is the FDA 510(k) clearance for PROVISION SURGICAL HELMET SYSTEM by Depuy, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972832 · Depuy, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
83d
Days
Class 2
Risk

K972832 is an FDA 510(k) clearance for the PROVISION SURGICAL HELMET SYSTEM. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 21, 1997 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K972832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1997
Decision Date October 21, 1997
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K972832.
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
MICROCOOL SURGICAL GOWN
K981393 · Kimberly-Clark Corp. · Jul 1998
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
K971920 · Customed, Inc. · Dec 1997
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
STRYKER STERI-SHIELD SURGICAL APPAREL
K944393 · Stryker Corp. · Aug 1995