IAMIN GEL WOUND DRESSING— 510(k) K953853

Clearance details

Applicant

Procyte Corp.

Product code

Code MGQ

Device class

Unclassified

Advisory panel

Unknown

Date received

1995-08-16

Decision date

1996-02-05

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Kirkland, WA, US

• K171879 — HylaGuard Moisturizing Cream2017-10-16
• K083024 — HYLATOPIC EMOLLIENT FOAM2009-03-27
• K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION2005-07-19
• K041268 — SILVERSITE OR CALGITROL2004-09-20
• K040019 — SILVERSEAL2004-07-23

• K971612 — OSMO/PCA PILLOW WOUND DRESSING1998-03-16
• K972150 — OSMOCYTE ISLAND WOUND DRESSING1997-12-10
• K972329 — OSMOCYTE RA WOUND DRESSING1997-12-10
• K970153 — LAMIN-2 HYDRATING GEL1997-06-05
• K965143 — OSMOCYTE WOUND MANAGER SHEET DRESSING1997-05-22

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 →

• Z-1516-2015 — Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.Class II·Terminated·PhotoMedex, Inc.·20150326

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953853.