Cleared Traditional

K923812 - CENTURION DISPOSABLE INSTRUMENTS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K923812 · Tri-State Hospital Supply Corp. · General & Plastic Surgery device
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Dec 1992
Decision
141d
Days
Class 1
Risk

K923812 is an FDA 510(k) clearance for the CENTURION DISPOSABLE INSTRUMENTS. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Tri-State Hospital Supply Corp. (Howell, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 141 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 Tri-State Hospital Supply Corp. devices

Submission Details

510(k) Number K923812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1992
Decision Date December 17, 1992
Days to Decision 141 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
27d slower than avg
Panel avg: 114d · This submission: 141d
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.