Cleared Traditional

K770261 - HOOD

K770261 is the FDA 510(k) clearance for HOOD by Sherwood Medical Industries. It is a Class 2 General Hospital device (product code FXY) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K770261 · Sherwood Medical Industries · General Hospital
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Mar 1977
Decision
18d
Days
Class 2
Risk

K770261 is an FDA 510(k) clearance for the HOOD, CLARION SURGEONS. Classified as Hood, Surgical (product code FXY), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977 after a review of 18 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 Sherwood Medical Industries devices

Submission Details

510(k) Number K770261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1977
Decision Date March 01, 1977
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXY Hood, 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 - FXY Hood, Surgical

All 7
Devices cleared under the same product code (FXY) and FDA review panel - the closest regulatory comparables to K770261.
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
K200493 · Stryker Corporation · Mar 2020
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
K140588 · Stryker Corporation · Jun 2014
DISPOSABLE BEARD COVER
K904276 · Anago, Inc. · Nov 1990
HOOD & BEARD COVER, CLARION SURGEON'S
K770257 · Sherwood Medical Industries · Feb 1977
BARRIER SURGICAL HOOD
K760855 · Surgikos, Inc. · Nov 1976
BARRIER FASHION BONNET
K760865 · Surgikos, Inc. · Nov 1976