Cleared Traditional

SURGI-TIE LOOPS (K861161) - FDA 510(k) Clearance

K861161 · Healthmed Corp. · General & Plastic Surgery device
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Jun 1986
Decision
74d
Days
-
Risk

K861161 is an FDA 510(k) clearance for the SURGI-TIE LOOPS.

Submitted by Healthmed Corp. (Fairport, US). The FDA issued a Cleared decision on June 10, 1986 after a review of 74 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 Healthmed Corp. devices

Submission Details

510(k) Number K861161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date June 10, 1986
Days to Decision 74 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
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -