Cleared Traditional

K925805 - KENDALL WOUND DRAINAGE SYSTEMS-TROCARS

K925805 is an FDA 510(k) clearance for KENDALL WOUND DRAINAGE SYSTEMS-TROCARS, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K925805 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
102d
Days
Class 1
Risk

K925805 is an FDA 510(k) clearance for the KENDALL WOUND DRAINAGE SYSTEMS-TROCARS. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on February 26, 1993 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K925805

510(k) Number K925805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date February 26, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 40
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K925805.
FLUID DRAINAGE TRAY
K926109 · Symbiosis Corp. · Jun 1993
KENDALL UNIVERSAL EXTENSION SET
K930551 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1993
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176 · Boston Scientific Corp · Apr 1993
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702 · Symbiosis Corp. · Jan 1993
SIL-MED FLAT SUCTION DRAIN
K921424 · Sil-Med Corp. · Sep 1992