Cleared Traditional

K863194 - TENDERM TAPE (FDA 510(k) Clearance)

K863194 · Lectec Corp. · General & Plastic Surgery device
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Sep 1986
Decision
42d
Days
-
Risk

K863194 is an FDA 510(k) clearance for the TENDERM TAPE.

Submitted by Lectec Corp. (Minnetonka, US). The FDA issued a Cleared decision on September 30, 1986 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 Lectec Corp. devices

Submission Details

510(k) Number K863194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1986
Decision Date September 30, 1986
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 -