Cleared Traditional

SURGITEK NPT MONITOR

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

About This 510(k) Submission

K875333 is an FDA 510(k) clearance for the SURGITEK NPT MONITOR, a Monitor, Penile Tumescence, submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on April 13, 1988, 105 days after receiving the submission on December 30, 1987. This device falls under the Gastroenterology & Urology review panel.

Submission Details

510(k) Number K875333 FDA.gov
FDA Decision Cleared 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 —

Device Classification

Product Code LIL — Monitor, Penile Tumescence
Device Class —

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