SPYROGEL HYDROGEL WOUND AND BURN DRESSING— 510(k) K982804

Substantially Equivalent for Some Indications

Innovative Technologies (Us), Inc.

FDA 510(k) clearance K982804 for SPYROGEL HYDROGEL WOUND AND BURN DRESSING, Substantially Equivalent for Some Indications on 1998-12-16. Applicant: Innovative Technologies (Us), Inc..

Clearance details

Applicant: Innovative Technologies (Us), Inc.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1998-08-10
Decision date: 1998-12-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Golden,, CO, US

Download summary PDF View on FDA.gov ↗

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.