AMERIGEL OINTMENT SATURATED WOUND DRESSING— 510(k) K971918
Substantially EquivalentAmerx Health Care Corp.
FDA 510(k) clearance K971918 for AMERIGEL OINTMENT SATURATED WOUND DRESSING, Substantially Equivalent on 1997-08-12. 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
- 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 K971918
K-number listed on FDA's recall record- Z-1797-2015 — Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
- Z-0497-2015 — Amerigel Hydrogel Wound Dressing Wound management
- Z-0498-2015 — Amerigel Post-op Surgical Kits Wound management
- Z-0499-2015 — Amerigel Daily Dressing Packets Wound management
- Z-0500-2015 — Amerigel Saturated Gauze Dressing Wound management
- Z-2638-2014 — Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
- Z-2639-2014 — Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.
- Z-2640-2014 — Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
- Z-2641-2014 — Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
- Z-1992-2014 — Amerigel Wound Dressing 1 oz. tube
- Z-1993-2014 — Amerigel Wound Dressing 55 gallons/drum
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971918.
Data sourced from openFDA. This site is unofficial and independent of the FDA.