Cleared Traditional

K934029 - STERILE LACERATION & DEBRIDEMENT TRAYS

K934029 is an FDA 510(k) clearance for STERILE LACERATION & DEBRIDEMENT TRAYS, manufactured by Surgipro, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K934029 · Surgipro, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
171d
Days
Class 2
Risk

K934029 is an FDA 510(k) clearance for the STERILE LACERATION & DEBRIDEMENT TRAYS. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Surgipro, Inc. (Palm Florida, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 171 days - an extended review cycle.

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 Surgipro, Inc. devices

FDA 510(k) Submission Details - K934029

510(k) Number K934029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 17, 1993
Decision Date February 04, 1994
Days to Decision 171 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
56d slower than avg
Panel avg: 115d · This submission: 171d
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 67
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K934029.
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994
CARAPACE STILLWATER BOWL SET
K931820 · Carapace, Inc. · Feb 1994
CARAPACE PACKING GAUZE TRAYS
K931760 · Carapace, Inc. · Feb 1994
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