Cleared Traditional

K980627 - NEVA SYSTEM

K980627 · Urometrics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K980627

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 131d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

All 25
Devices cleared under the same product code (LIL) and FDA review panel - the closest regulatory comparables to K980627.
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K940128 · Farrall Instruments, Inc. · Jan 1995
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
K941781 · Dacomed Corp. · Aug 1994
K980627 · NEVA SYSTEM
Download PDF FDA Summary Urometrics, Inc.