Cleared Traditional

K972612 - DISSECTRON PORTABLE UNIT

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

FDA 510(k) Submission Details - K972612

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

63d faster than avg

Panel avg: 149d · This submission: 86d

Pathway characteristics

Predicate-based equivalence.

LBK Device Classification - Class 0,

Product Code	LBK Neurosurgical Ultrasonic Instruments
Device Class	-

Regulatory Peers - LBK Neurosurgical Ultrasonic Instruments

Devices cleared under the same product code (LBK) and FDA review panel - the closest regulatory comparables to K972612.

OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)

K962952 · Olympus Optical, Co. · Nov 1996

CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.

K884412 · Valleylab, Inc. · Dec 1988

CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR

K884413 · Valleylab, Inc. · Dec 1988

COOPER LASER SONICS CUSA MODEL 200

K853143 · Cooper Lasersonics, Inc. · Oct 1985

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K972612

Satelec

Wellesley, MA · US

JACKIE MASSE

Regulatory profile

24 submissions 24 cleared

100% clearance rate · Active in Neurology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 8, 1997. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,325

Regulatory data since 1976

FDA monthly sync October 7, 2026