Cleared Traditional

K852180 - SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. (FDA 510(k) Clearance)

K852180 · Surgidyne, Inc. · General & Plastic Surgery device
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Jul 1985
Decision
42d
Days
-
Risk

K852180 is an FDA 510(k) clearance for the SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC..

Submitted by Surgidyne, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Surgidyne, Inc. devices

Submission Details

510(k) Number K852180 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 20, 1985
Decision Date July 01, 1985
Days to Decision 42 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
72d faster than avg
Panel avg: 114d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -