Cleared Traditional

K934428 - ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY

K934428 is an FDA 510(k) clearance for ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCE..., manufactured by Sherwood Medical Co.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K934428 · Sherwood Medical Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
111d
Days
Class 2
Risk

K934428 is an FDA 510(k) clearance for the ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 30, 1993 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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 - K934428

510(k) Number K934428 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 10, 1993
Decision Date December 30, 1993
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRO Device Classification - Class 2, Special Controls

Product Code LRO General Surgery Tray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRO General Surgery Tray

All 66
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K934428.
CARAPACE WOUND DRESSING KITS & LACERATION TRAYS
K931758 · Carapace, Inc. · Jan 1994
CARAPACE STERILE GAUZE TRAYS
K931759 · Carapace, Inc. · Jan 1994
CARAPACE CATARACT TRAYS
K931673 · Carapace, Inc. · Dec 1993
CARAPACE INSTRUMLENT AND INSTRUMENT SETS
K931824 · Carapace, Inc. · Dec 1993
MAJOR, MINOR, BASIN TRAYS (PACKS)
K932217 · Associated Medical Products Co. · Nov 1993
LAP CHOLY TRAYS (PACKS)
K932220 · Associated Medical Products Co. · Sep 1993