DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING— 510(k) K961085

Name: FDA 510(k) clearance K961085
Creator: U.S. Food and Drug Administration
Published: 1996-05-21

Substantially Equivalent

Debusk Knitting Mills, Div. Deroyal Industries

FDA 510(k) clearance K961085 for DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING, Substantially Equivalent on 1996-05-21. Applicant: Debusk Knitting Mills, Div. Deroyal Industries. Device class: Unclassified.

Clearance details

Applicant: Debusk Knitting Mills, Div. Deroyal Industries
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-03-19
Decision date: 1996-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

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K961097 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES1996-06-03
K961087 — DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS1996-05-16
K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER1996-01-11

Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.