Home / 510(k) Clearances / K970518

510(k) K970518

ALGOPLAQUE HYDROCOLLOID DRESSING by Laboratoires Urgo S.A. — Product Code MGP

K970518 is an FDA 510(k) premarket notification submitted by Laboratoires Urgo S.A. for the device "ALGOPLAQUE HYDROCOLLOID DRESSING". The FDA issued a decision of Substantially Equivalent for Some Indications on Mar 21, 1997. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Laboratoires Urgo S.A. has 7 other 510(k) clearances on record.

Clearance details

Decision
SN (Substantially Equivalent for Some Indications)
Decision Date
Mar 21, 1997
Date Received
Feb 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Laboratoires Urgo S.A.

  • K143017 — Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver (Aug 7, 2015)
  • K123219 — URGOCLEAN ABSORBENT WOUND DRESSING (Mar 18, 2013)
  • K100429 — URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (Jun 11, 2010)
  • K100430 — URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER (Jun 11, 2010)
  • K062559 — URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER (Jan 29, 2007)
  • K061220 — URGOTUL AG (Jul 27, 2006)
  • K974348 — ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING (Feb 13, 1998)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (Oct 25, 2001)
  • K012997 — COLLATEK FOAM (Oct 25, 2001)
  • K001508 — LASERSKIN DRESSING (Jul 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (Dec 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (Oct 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (Sep 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (Sep 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND… (Mar 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (Mar 3, 1999)

FDA data resources

Source: FDA 510(k) database entry for K970518. Report a data issue: hello@regdatalab.com.