Cleared Traditional

K933510 - ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER

K933510 is an FDA 510(k) clearance for ARGYLE TURKEL SAFETY TROCAR THORACIC CA..., manufactured by Sherwood Medical Co.. The device is a Class 1 General & Plastic Surgery device with product code GBW cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K933510 · Sherwood Medical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
219d
Days
Class 1
Risk

K933510 is an FDA 510(k) clearance for the ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on February 24, 1994 after a review of 219 days - an extended review cycle.

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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K933510

510(k) Number K933510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date February 24, 1994
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence.

GBW Device Classification - Class 1, General Controls

Product Code GBW Catheter, Peritoneal
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 - GBW Catheter, Peritoneal

All 13
Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K933510.
ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN
K961194 · Sil-Med Corp. · Aug 1996
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
K960426 · Medical Components, Inc. · Mar 1996
MEDIASTINAL SILICONE DRAINS
K942709 · Sil-Med Corp. · Jan 1996
BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO
K926477 · Core Dynamics, Inc. · Nov 1993
NELSON-JUNG PLEURAL CATH
K854812 · Research Medical, Inc. · Feb 1986
DERBYSHIRE DRAIN
K843575 · Sil-Med Corp. · Oct 1984