WATER JEL STERILE GEL-SOAKED BURN DRESSING— 510(k) K885321

Name: FDA 510(k) clearance K885321
Creator: U.S. Food and Drug Administration
Published: 1989-03-22

Substantially Equivalent for Some Indications

Pfizer Pharmaceuticals

FDA 510(k) clearance K885321 for WATER JEL STERILE GEL-SOAKED BURN DRESSING, Substantially Equivalent for Some Indications on 1989-03-22. Applicant: Pfizer Pharmaceuticals. Device class: Unclassified.

Clearance details

Applicant: Pfizer Pharmaceuticals
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1988-12-28
Decision date: 1989-03-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ny, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

view all

K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Pfizer Pharmaceuticals

view all

K810427 — CEFOTAXIME 30MCG ANTIMICROBIAL SUSCEP.1981-03-31
K802408 — E-VAC BLOOD CULTURE SYSTEM1980-10-23
K771605 — CREATINE KINASE ISOENZYME SUBSTRATE SET1977-09-15
K770801 — MICROBIO. PROD. FLUORESCENT ANTIBODY1977-05-25
K770425 — NEEDLES, STERILE, AIRWAY1977-04-15

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.