Cleared Traditional

K933137 - ACU-SUTURE KIT

K933137 is an FDA 510(k) clearance for ACU-SUTURE KIT, manufactured by Acuderm, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K933137 · Acuderm, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
239d
Days
Class 2
Risk

K933137 is an FDA 510(k) clearance for the ACU-SUTURE KIT. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Acuderm, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 239 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 Acuderm, Inc. devices

FDA 510(k) Submission Details - K933137

510(k) Number K933137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date February 22, 1994
Days to Decision 239 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
124d slower than avg
Panel avg: 115d · This submission: 239d
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 K933137.
INSTRUMENT TRAY
K935743 · Cush Medical Products · Mar 1994
CENTRAL LINE TRAY
K936117 · Cush Medical Products · Mar 1994
DRESSING CHANGE TRAY
K935686 · Cush Medical Products · Feb 1994
IRRIGATION TRAY
K935740 · Cush Medical Products · Feb 1994
MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
K935858 · Mill-Rose Laboratory · Feb 1994
O.R. BASIN SET TRAY
K935741 · Cush Medical Products · Feb 1994