Cleared Traditional

K913678 - TROCAR CATHETER (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K913678 · Medovations, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
119d
Days
Class 1
Risk

K913678 is an FDA 510(k) clearance for the TROCAR CATHETER. Classified as Bag, Intestine (product code KGY), Class I - General Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 16, 1991 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4100 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medovations, Inc. devices

Submission Details

510(k) Number K913678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date December 16, 1991
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 114d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGY Bag, Intestine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4100
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.