Cleared Traditional

K870283 - 3 X 3 SPONGES

K870283 is the FDA 510(k) clearance for 3 X 3 SPONGES by The Medical Group, Inc.. It is a Class 1 General & Plastic Surgery device (product code NAB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K870283 · The Medical Group, Inc. · General & Plastic Surgery device
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Feb 1987
Decision
28d
Days
Class 1
Risk

K870283 is an FDA 510(k) clearance for the 3 X 3 SPONGES, NON-STERILE. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by The Medical Group, Inc. (Reno, US). The FDA issued a Cleared decision on February 24, 1987 after a review of 28 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 The Medical Group, Inc. devices

Submission Details

510(k) Number K870283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1987
Decision Date February 24, 1987
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 19
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K870283.
PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLE
K920282 · Trinity Laboratories, Inc. · May 1992
NON-ABSORBABLE GAUZE, SURGICAL SPONGE & DRESSING
K891101 · Smith & Nephew United, Inc. · Apr 1989
ABSORBENT GAUZE ROLL
K890672 · Smith & Nephew United, Inc. · Apr 1989
TRICOTEX WOUND CONTACT LAYER DRESSING
K864264 · Smith & Nephew, Inc. · Dec 1986
AN ODOR ABSORBENT BANDAGE
K833735 · American Medical Disposable, Inc. · Apr 1984
FEMORAL CANAL SPONGE
K831886 · Zimmer, Inc. · Sep 1983