Cleared Traditional

K860030 - SURGIDYNE VARIDYNE

K860030 is the FDA 510(k) clearance for SURGIDYNE VARIDYNE by Surgidyne, Inc.. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K860030 · Surgidyne, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
37d
Days
Class 2
Risk

K860030 is an FDA 510(k) clearance for the SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Surgidyne, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on February 12, 1986 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 878.4780 - 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 Surgidyne, Inc. devices

Submission Details

510(k) Number K860030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date February 12, 1986
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. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 39
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K860030.
COOK ASPIRATION/IRRIGATION UNIT
K944818 · Cook Urological, Inc. · Nov 1994
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co. · Aug 1986
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
SYSTEC 280 INTEGRATED SUCTION SYSTEM
K791349 · Stryker Corp. · Sep 1979