Cleared Traditional

K882115 - A-SORB

K882115 is an FDA 510(k) clearance for A-SORB, manufactured by Howard Medical Co.. The device is a Class 1 General & Plastic Surgery device with product code NAB cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K882115 · Howard Medical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
137d
Days
Class 1
Risk

K882115 is an FDA 510(k) clearance for the A-SORB. Classified as Gauze / Sponge,nonresorbable For External Use (product code NAB), Class I - General Controls.

Submitted by Howard Medical Co. (Chicago, US). The FDA issued a Cleared decision on October 3, 1988 after a review of 137 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Howard Medical Co. devices

FDA 510(k) Submission Details - K882115

510(k) Number K882115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1988
Decision Date October 03, 1988
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence.

NAB Device Classification - Class 1, General Controls

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 34
Devices cleared under the same product code (NAB) and FDA review panel - the closest regulatory comparables to K882115.
POST OPERATIVE SPONGE
K912693 · Ulti-Med Intl., Inc. · Oct 1991
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