Cleared Traditional

K830786 - DISIMETRIC RELEASE OF INSTRANETICS RAD

K830786 is the FDA 510(k) clearance for DISIMETRIC RELEASE OF INSTRANETICS RAD by American Convertors Div., American Pharmaseal. It is a Class 1 Gastroenterology & Urology device (product code KOA) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K830786 · American Convertors Div., American Pharmaseal · Gastroenterology & Urology device
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May 1983
Decision
68d
Days
Class 1
Risk

K830786 is an FDA 510(k) clearance for the DISIMETRIC RELEASE OF INSTRANETICS RAD. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by American Convertors Div., American Pharmaseal (Mchenry, US). The FDA issued a Cleared decision on May 18, 1983 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - the FDA gastroenterology and urology 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 American Convertors Div., American Pharmaseal devices

Submission Details

510(k) Number K830786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1983
Decision Date May 18, 1983
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
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 - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 25
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K830786.
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