Cleared Traditional

K853597 - INSTRUMENT MAKAR DISPOSALBE LOOP (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K853597 · Instrument Makar, Inc. · General & Plastic Surgery device
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Sep 1985
Decision
27d
Days
Class 1
Risk

K853597 is an FDA 510(k) clearance for the INSTRUMENT MAKAR DISPOSALBE LOOP. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Instrument Makar, Inc. (Washington, US). The FDA issued a Cleared decision on September 23, 1985 after a review of 27 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 Instrument Makar, Inc. devices

Submission Details

510(k) Number K853597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1985
Decision Date September 23, 1985
Days to Decision 27 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
87d faster than avg
Panel avg: 114d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDC Instrument, Surgical, Disposable
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.