Cleared Traditional

K823854 - MEDCARE SUTURE REMOVAL TRAYS

K823854 is an FDA 510(k) clearance for MEDCARE SUTURE REMOVAL TRAYS, manufactured by Medcare Products. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K823854 · Medcare Products · General & Plastic Surgery device
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Mar 1983
Decision
99d
Days
Class 1
Risk

K823854 is an FDA 510(k) clearance for the MEDCARE SUTURE REMOVAL TRAYS. 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 March 31, 1983 after a review of 99 days - within the typical 510(k) review window.

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: 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 Medcare Products devices

FDA 510(k) Submission Details - K823854

510(k) Number K823854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1982
Decision Date March 31, 1983
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

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 38
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K823854.
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
K840976 · Carapace, Inc. · May 1984
TRACHEOSTOMY CARE TRAY
K841122 · Medcare Products · Apr 1984
CONVERTORS FLASH STERILIZING TRAY
K832137 · American Convertors Div., American Pharmaseal · Aug 1983
HANDI-TRAY
K823438 · Treace Medical, Inc. · Jan 1983
MEDCARE WOUND CLOSURE TRAY
K823853 · Medcare Products · Jan 1983
MEDCARE INCISION & DRAINAGE TRAY
K823855 · Medcare Products · Jan 1983