Cleared Traditional

K890436 - TECHNOMED PULSOLITH LASER SYSTEM

K890436 is an FDA 510(k) clearance for TECHNOMED PULSOLITH LASER SYSTEM, manufactured by Teknomed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K890436 · Teknomed, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
55d
Days
Class 2
Risk

K890436 is an FDA 510(k) clearance for the TECHNOMED PULSOLITH LASER SYSTEM. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Teknomed, Inc. (Danvers, US). The FDA issued a Cleared decision on March 23, 1989 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - the FDA gastroenterology and urology device framework. 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 Teknomed, Inc. devices

FDA 510(k) Submission Details - K890436

510(k) Number K890436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date March 23, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFK Device Classification - Class 2, Special Controls

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FFK Lithotriptor, Electro-hydraulic

All 31
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K890436.
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914514 · Northgate Technologies, Inc. · Jan 1992
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K913955 · Northgate Technologies, Inc. · Nov 1991
MDL-1 LASERTRIPTER(TM)
K885255 · Candela Laser Corp. · Jun 1989
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · KARL STORZ Endoscopy-America, Inc. · Feb 1989
MDL-1 LASERTRIPTER
K880503 · Candela Laser Corp. · Jun 1988
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · Candela Corp. · Dec 1986