Cleared Traditional

K864963 - STOMACH EVACULATOR - EWALD STYLE

K864963 is an FDA 510(k) clearance for STOMACH EVACULATOR - EWALD STYLE, manufactured by Medovations, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code KOA cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K864963 · Medovations, Inc. · Gastroenterology & Urology device
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Oct 1987
Decision
296d
Days
Class 1
Risk

K864963 is an FDA 510(k) clearance for the STOMACH EVACULATOR - EWALD STYLE. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 14, 1987 after a review of 296 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medovations, Inc. devices

FDA 510(k) Submission Details - K864963

510(k) Number K864963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date October 14, 1987
Days to Decision 296 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
165d slower than avg
Panel avg: 131d · This submission: 296d
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 29
Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K864963.
VAS DILATOR
K922192 · Cook Urological, Inc. · Aug 1992
GRASPING FORCEPS
K896058 · Annex Medical, Inc. · Dec 1989
MICROSURGICAL CYSTOTOME
K890218 · Kinetic Medical Products · Jan 1989
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
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
K851162 · Van-Tec, Inc. · Apr 1985