Cleared Traditional

K863565 - MENTOR ALLOPLASTIC SPERMATOCELE (FDA 510(k) Clearance)

K863565 · Mentor Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
68d
Days
-
Risk

K863565 is an FDA 510(k) clearance for the MENTOR ALLOPLASTIC SPERMATOCELE. Classified as Spermatocele, Alloplastic (product code LQS).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on November 19, 1986 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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 Mentor Corp. devices

Submission Details

510(k) Number K863565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date November 19, 1986
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQS Spermatocele, Alloplastic
Device Class -