Cleared Traditional

K791726 - HYDROGEL-PREP

K791726 is the FDA 510(k) clearance for HYDROGEL-PREP by Spenco Medical Corp.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K791726 · Spenco Medical Corp. · General & Plastic Surgery device
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Nov 1979
Decision
77d
Days
Class 1
Risk

K791726 is an FDA 510(k) clearance for the HYDROGEL-PREP. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Spenco Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4014 - 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 Spenco Medical Corp. devices

Submission Details

510(k) Number K791726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1979
Decision Date November 20, 1979
Days to Decision 77 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NAB Gauze / Sponge,nonresorbable For External Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
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 - NAB Gauze / Sponge,nonresorbable For External Use

All 20
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K791726.
TRIANGULAR BANDAGE
K811814 · Abco Dealers, Inc. · Jul 1981
BONE-DRI SURGICAL SPONGE
K803125 · Howmedica Corp. · Jan 1981
GUAZE BANDAGES CAT.#101-169
K801996 · Pollak (Intl.), Ltd. · Sep 1980
HAND TOWEL
K791926 · Procter & Gamble Mfg. Co. · Oct 1979
DEXIDE DISPOSABLE PREP SPONGE
K791166 · Dexide, Inc. · Jul 1979
GAUZE SPONGES
K780795 · Abco Dealers, Inc. · Jun 1978