Cleared Traditional

K823853 - MEDCARE WOUND CLOSURE TRAY

K823853 is the FDA 510(k) clearance for MEDCARE WOUND CLOSURE TRAY by Medcare Products. It is a Class 1 General & Plastic Surgery device (product code FSM) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K823853 · Medcare Products · General & Plastic Surgery device
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Jan 1983
Decision
23d
Days
Class 1
Risk

K823853 is an FDA 510(k) clearance for the MEDCARE WOUND CLOSURE TRAY. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Medcare Products (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Medcare Products devices

Submission Details

510(k) Number K823853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1982
Decision Date January 14, 1983
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - FSM Tray, Surgical, Instrument

All 21
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K823853.
STERILIZATION TRAY, TMJ INSTRUMENT SET
K871924 · Arthropedics, Inc. · Jun 1987
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY
K870892 · Medsurg Industries, Inc. · Apr 1987
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
OPERATING ROOM KIT
K811916 · American Hospital Supply Corp. · Oct 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC
K802964 · Associated Medical Products Co. · Jan 1981
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · Associated Medical Products Co. · Jan 1981