Cleared Traditional

K982260 - MARKWELL GAUZE SPONGE

K982260 is an FDA 510(k) clearance for MARKWELL GAUZE SPONGE, manufactured by Markwell Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code LWH cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K982260 · Markwell Intl., Inc. · General & Plastic Surgery device
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Aug 1998
Decision
47d
Days
Class 1
Risk

K982260 is an FDA 510(k) clearance for the MARKWELL GAUZE SPONGE. Classified as Counter, Sponge, Surgical (product code LWH), Class I - General Controls.

Submitted by Markwell Intl., Inc. (Alhambra, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 47 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2740 - 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.

FDA 510(k) Submission Details - K982260

510(k) Number K982260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1998
Decision Date August 12, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

LWH Device Classification - Class 1, General Controls

Product Code LWH Counter, Sponge, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
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 - LWH Counter, Sponge, Surgical

All 14
Devices cleared under the same product code (LWH) and FDA review panel - the closest regulatory comparables to K982260.
MEDLINE SURGICAL SPONGE SCANNER
K061316 · Medline Industries, Inc. · Nov 2006
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A
K062642 · Rf Surgical Systems, Inc. · Nov 2006
SURGICOUNT SAFETY-SPONGE SYSTEM
K060076 · Surgicount Medical · Mar 2006
POCKET COUNT OR SAFETCOUNT
K972302 · Sage Products, Inc. · Jul 1997
SPONGE COUNT
K945144 · Michael Fischer Assoc. · Jan 1995
DEVON SPONGE COUNTER BAGS
K912824 · Devon Industries, Inc. · Aug 1991
K982260 · MARKWELL GAUZE SPONGE
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