PANOGAUZE NON-WOVEN HYDROGEL DRESSING— 510(k) K964620

Substantially Equivalent for Some Indications

Sage Pharmaceuticals, Inc.

FDA 510(k) clearance K964620 for PANOGAUZE NON-WOVEN HYDROGEL DRESSING, Substantially Equivalent for Some Indications on 1997-01-09. Applicant: Sage Pharmaceuticals, Inc..

Clearance details

Applicant: Sage Pharmaceuticals, Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1996-11-18
Decision date: 1997-01-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Shreveport, LA, US

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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.