Cleared Traditional

K972612 - DISSECTRON PORTABLE UNIT (FDA 510(k) Clearance)

K972612 · Satelec · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
86d
Days
-
Risk

K972612 is an FDA 510(k) clearance for the DISSECTRON PORTABLE UNIT. Classified as Neurosurgical Ultrasonic Instruments (product code LBK).

Submitted by Satelec (Wellesley, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Satelec devices

Submission Details

510(k) Number K972612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date October 08, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBK Neurosurgical Ultrasonic Instruments
Device Class -