Cleared Traditional

K963715 - DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY

K963715 is an FDA 510(k) clearance for DEBRIDEMENT TRAY, manufactured by Grand Medical Products. The device is a Class 2 General & Plastic Surgery device with product code LRO cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K963715 · Grand Medical Products · General & Plastic Surgery device
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Nov 1996
Decision
72d
Days
Class 2
Risk

K963715 is an FDA 510(k) clearance for the DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY. Classified as General Surgery Tray (product code LRO), Class II - Special Controls.

Submitted by Grand Medical Products (Schaumburg, US). The FDA issued a Cleared decision on November 27, 1996 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Grand Medical Products devices

FDA 510(k) Submission Details - K963715

510(k) Number K963715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date November 27, 1996
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
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 65
Devices cleared under the same product code (LRO) and FDA review panel - the closest regulatory comparables to K963715.
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
K965201 · Trinity Laboratories, Inc. · Feb 1997
RUNYON LARGE VOLUME PARACENTESIS KIT
K970187 · Gi Supply · Feb 1997
BASIC BIOPSY TRAY. DISPOSABLE, STERILE
K964921 · Trinity Laboratories, Inc. · Jan 1997
SKIN SCRUB TRAY
K963721 · Grand Medical Products · Nov 1996
SUCTION CATHETER TRAY PRODUCT NO. 900277
K964011 · Customed, Inc. · Nov 1996
PROD. NO. 02-031 - LACERATION TRAY
K963443 · Continental Medical Laboratories, Inc. · Oct 1996