510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963715Substantially Equivalent

Debridement Tray, Incision and Drainage Tray

Grand Medical Products, Schaumburg IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963715 is the FDA 510(k) clearance record for DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY, a class II device, cleared for Grand Medical Products on under FDA product code LRO (General Surgery Tray). FDA's definition for product code LRO reads: "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...". FDA records list 8 510(k) clearances for Grand Medical Products, from to . As of , FDA records show no recalls naming K963715.

Clearance record

Decision date
Received
(72 days to decision)
Product code
LRO General Surgery Tray
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Grand Medical Products 1300 Remington Rd., Suite K, Schaumburg IL
510(k) summary
Statement
Third party review
No

Clearances, product code LRO

Trailing 12 months

FDA records hold no clearances under product code LRO in the trailing twelve months.

FDA records show no clearances under product code LRO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260