Cleared Traditional

K851646 - VIBRECTOR

K851646 · Multicept, Aps. · Gastroenterology & Urology device
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Aug 1985
Decision
124d
Days
-
Risk

K851646 is an FDA 510(k) clearance for the VIBRECTOR. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Multicept, Aps. (Copenhagen, DK). The FDA issued a Cleared decision on August 21, 1985 after a review of 124 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Multicept, Aps. devices

FDA 510(k) Submission Details - K851646

510(k) Number K851646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1985
Decision Date August 21, 1985
Days to Decision 124 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
7d faster than avg
Panel avg: 131d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

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K831251 · Life-Tech Intl., Inc. · Jun 1983