Cleared Traditional

K923600 - ENDO OPTIKS VALUE PACK

K923600 is an FDA 510(k) clearance for ENDO OPTIKS VALUE PACK, manufactured by Endo Optics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K923600 · Endo Optics, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1993
Decision
246d
Days
Class 2
Risk

K923600 is an FDA 510(k) clearance for the ENDO OPTIKS VALUE PACK. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Endo Optics, Inc. (Marlboro, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 246 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 Endo Optics, Inc. devices

FDA 510(k) Submission Details - K923600

510(k) Number K923600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 20, 1992
Decision Date March 23, 1993
Days to Decision 246 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
131d slower than avg
Panel avg: 115d · This submission: 246d
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 K923600.
MEDSURG O.R. PROCEDURE TRAY
K914037 · Medsurg Industries, Inc. · Jun 1993
PREP SHAVE KIT (NON-STERILE)
K925016 · Customed, Inc. · Apr 1993
DYONICS ARTHROSCOPIC KIT
K920267 · Smith & Nephew Dyonics, Inc. · Mar 1993
ACE CUSTOM SURGICAL PACK
K922648 · Ace Surgical Supply Co., Inc. · Mar 1993
MEDSURG LAPAROSCOPY TRAY
K914036 · Medsurg Industries, Inc. · Mar 1992
STERILE DISPOSABLE WET SKIN SCRUB TRAY
K914174 · Medical Device Inspection Co., Inc. · Feb 1992