Cleared Traditional

K770259 - CAP

K770259 is the FDA 510(k) clearance for CAP by Sherwood Medical Industries. It is a Class 1 General & Plastic Surgery device (product code FYF) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K770259 · Sherwood Medical Industries · General & Plastic Surgery device
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Mar 1977
Decision
24d
Days
Class 1
Risk

K770259 is an FDA 510(k) clearance for the CAP, CLARION SURGEON'S. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on March 7, 1977 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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 K770259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1977
Decision Date March 07, 1977
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FYF Cap, Surgical

All 9
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K770259.
DISPOSABLE SURGERY CAPS & HOODS
K810199 · Anago, Inc. · Feb 1981
DISPOSABLE NURSES CAP
K802186 · Anago, Inc. · Sep 1980
CAP, CLARION NURSES, STYLE BOUFFANT 21
K770258 · Sherwood Medical Industries · Mar 1977
CAP, CLARION NURSES OR (TECHNIC)
K770260 · Sherwood Medical Industries · Mar 1977
SURGICAL CORP.
K760861 · Surgikos, Inc. · Nov 1976