Cleared Traditional

K832186 - HALL DRILL/REAMER

K832186 is the FDA 510(k) clearance for HALL DRILL/REAMER by Amsco Co.. It is a Class 1 General & Plastic Surgery device (product code GET) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K832186 · Amsco Co. · General & Plastic Surgery device
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Aug 1983
Decision
37d
Days
Class 1
Risk

K832186 is an FDA 510(k) clearance for the HALL DRILL/REAMER. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General Controls.

Submitted by Amsco Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Amsco Co. devices

Submission Details

510(k) Number K832186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1983
Decision Date August 12, 1983
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - GET Motor, Surgical Instrument, Pneumatic Powered

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