DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY— 510(k) K963715

Name: FDA 510(k) clearance K963715
Creator: U.S. Food and Drug Administration
Published: 1996-11-27

Substantially Equivalent

Grand Medical Products

FDA 510(k) clearance K963715 for DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY, Substantially Equivalent on 1996-11-27. Applicant: Grand Medical Products. Device class: 2.

Clearance details

Applicant: Grand Medical Products
Product code: Code LRO
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1996-09-16
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Grand Medical Products

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K963724 — GAUZE SPONGE, NON X-RAY DETECTABLE1996-11-29
K963714 — GRAND MEDICAL SUTURE REMOVAL KIT1996-11-27
K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY1996-11-27
K963720 — TRACHEOSTOMY KIT1996-11-27
K963721 — SKIN SCRUB TRAY1996-11-27

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.