AMERIGEL OINTMENT— 510(k) K970133
Substantially Equivalent for Some IndicationsAmerx Health Care Corp.
FDA 510(k) clearance K970133 for AMERIGEL OINTMENT, Substantially Equivalent for Some Indications on 1997-04-14. Applicant: Amerx Health Care Corp.. Device class: Unclassified.
Clearance details
- Applicant
- Amerx Health Care Corp.
- Product code
- Code MGQ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Recent devices under product code MGQ
view allMore clearances from Amerx Health Care Corp.
view allAdverse events under product code MGQ
product code MGQ- Death
- 16
- Total
- 16
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K970133
K-number listed on FDA's recall record- Z-2249-2016 — Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
- Z-1797-2015 — Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970133.
Data sourced from openFDA. This site is unofficial and independent of the FDA.