Cleared Traditional

K980627 - NEVA SYSTEM (FDA 510(k) Clearance)

K980627 · Urometrics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
48d
Days
-
Risk

K980627 is an FDA 510(k) clearance for the NEVA SYSTEM. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Urometrics, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 7, 1998 after a review of 48 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 Urometrics, Inc. devices

Submission Details

510(k) Number K980627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date April 07, 1998
Days to Decision 48 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -