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510(k) K946245

TIELLE* HYDROPOLYMER DRESSING by Johnson & Johnson International — Product Code KMF

K946245 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "TIELLE* HYDROPOLYMER DRESSING". The FDA issued a decision of Substantially Equivalent on April 11, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Johnson & Johnson International has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1995
Date Received
December 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Johnson & Johnson International

  • K965198 — ULTIMA TPS CEMENTED STEM (July 23, 1997)
  • K944937 — SYNTHETIC ABSORBABLE SUTURE (May 19, 1995)
  • K942383 — DERMIVIEW CLEAR TAPE (August 22, 1994)
  • K922918 — BARRIER SAF-TE HYDROGEL DRAPE (July 6, 1993)
  • K923807 — P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS (November 9, 1992)
  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
  • K901456 — ORTHOSORB(R) ABSORBABLE PIN (August 15, 1990)
  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)
  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

Other clearances for product code KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources