Cleared Traditional

K890218 - MICROSURGICAL CYSTOTOME

K890218 is an FDA 510(k) clearance for MICROSURGICAL CYSTOTOME, manufactured by Kinetic Medical Products. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K890218 · Kinetic Medical Products · Gastroenterology & Urology device
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Jan 1989
Decision
9d
Days
Class 1
Risk

K890218 is an FDA 510(k) clearance for the MICROSURGICAL CYSTOTOME. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 Kinetic Medical Products devices

FDA 510(k) Submission Details - K890218

510(k) Number K890218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date January 27, 1989
Days to Decision 9 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 130d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

KOA Device Classification - Class 1, General Controls

Product Code KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 24
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K890218.
VASOVASOSTOMY SET
K921546 · Cook Urological, Inc. · Jul 1993
NO-SCALPEL VASCETOMY INSTRUMENTS
K922971 · Pilling Co. · Sep 1992
VAS DILATOR
K922192 · Cook Urological, Inc. · Aug 1992
STOMACH EVACULATOR - EWALD STYLE
K864963 · Medovations, Inc. · Oct 1987
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K852725 · The Huxley Instrument Corp. · Jul 1985
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K852726 · The Huxley Instrument Corp. · Jul 1985