Cleared Traditional

SEAGER ELECTROEJACULATOR (K962379) - FDA 510(k) Clearance

K962379 · National Rehab Hospital · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
455d
Days
-
Risk

K962379 is an FDA 510(k) clearance for the SEAGER ELECTROEJACULATOR. Classified as Stimulator, Electrical For Sperm Collection (product code LNL).

Submitted by National Rehab Hospital (Washington, US). The FDA issued a Cleared decision on September 18, 1997 after a review of 455 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all National Rehab Hospital devices

Submission Details

510(k) Number K962379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date September 18, 1997
Days to Decision 455 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
325d slower than avg
Panel avg: 130d · This submission: 455d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LNL Stimulator, Electrical For Sperm Collection
Device Class -