Cleared Traditional

K875333 - SURGITEK NPT MONITOR

K875333 · Surgitek · Gastroenterology & Urology device
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Apr 1988
Decision
105d
Days
-
Risk

K875333 is an FDA 510(k) clearance for the SURGITEK NPT MONITOR. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 105 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.

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FDA 510(k) Submission Details - K875333

510(k) Number K875333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1987
Decision Date April 13, 1988
Days to Decision 105 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 131d · This submission: 105d
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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