HYCOAT— 510(k) K960686

Name: FDA 510(k) clearance K960686
Creator: U.S. Food and Drug Administration
Published: 1996-08-12

Substantially Equivalent for Some Indications

The Hymed Group Corp.

FDA 510(k) clearance K960686 for HYCOAT, Substantially Equivalent for Some Indications on 1996-08-12. Applicant: The Hymed Group Corp.. Device class: Unclassified.

Clearance details

Applicant: The Hymed Group Corp.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1996-02-20
Decision date: 1996-08-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MGQ

view all

K171879 — HylaGuard Moisturizing Cream2017-10-16
K083024 — HYLATOPIC EMOLLIENT FOAM2009-03-27
K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION2005-07-19
K041268 — SILVERSITE OR CALGITROL2004-09-20
K040019 — SILVERSEAL2004-07-23

More clearances from The Hymed Group Corp.

view all

K132891 — HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER2014-06-19
K061227 — HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER2006-12-20
K994339 — HYCURE ORAL / HYCURE ORAL SMART GEL2000-03-22
K961930 — CHONDROPROTEC1996-10-15
K955506 — HYCURE1996-01-17

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.