Cleared Traditional

PARAGON MICRO-LOOPS (K860022) - FDA 510(k) Clearance

K860022 · Paragon Medical and Scientific, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1986
Decision
80d
Days
-
Risk

K860022 is an FDA 510(k) clearance for the PARAGON MICRO-LOOPS.

Submitted by Paragon Medical and Scientific, Inc. (Saint Paul, US). The FDA issued a Cleared decision on March 24, 1986 after a review of 80 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 Paragon Medical and Scientific, Inc. devices

Submission Details

510(k) Number K860022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date March 24, 1986
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -