Cleared Traditional

K803125 - BONE-DRI SURGICAL SPONGE

K803125 is the FDA 510(k) clearance for BONE-DRI SURGICAL SPONGE by Howmedica Corp.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K803125 · Howmedica Corp. · General & Plastic Surgery device
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Jan 1981
Decision
34d
Days
Class 1
Risk

K803125 is an FDA 510(k) clearance for the BONE-DRI SURGICAL SPONGE. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981 after a review of 34 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 Howmedica Corp. devices

Submission Details

510(k) Number K803125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date January 15, 1981
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 13
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K803125.
UNIFLEX
K820470 · Howmedica Corp. · Jun 1982
HOLLISTER ODOR ABSORBING WOUND PAD
K820464 · Hollister, Inc. · Mar 1982
TRIANGULAR BANDAGE
K811814 · Abco Dealers, Inc. · Jul 1981
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