Cleared Traditional

SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT (K923281) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K923281 · Savoy Medical Supply Co., Inc. · General & Plastic Surgery device
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Mar 1993
Decision
263d
Days
Class 1
Risk

K923281 is an FDA 510(k) clearance for the SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Savoy Medical Supply Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on March 26, 1993 after a review of 263 days - an extended review 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: 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 Savoy Medical Supply Co., Inc. devices

Submission Details

510(k) Number K923281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date March 26, 1993
Days to Decision 263 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 115d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MDM Instrument, Manual, Surgical, General Use
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.