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510(k) K083752

GLUSEAL 90, MODEL GLU9010 by Glustitch, Inc. — Product Code KMF

K083752 is an FDA 510(k) premarket notification submitted by Glustitch, Inc. for the device "GLUSEAL 90, MODEL GLU9010". The FDA issued a decision of Substantially Equivalent on February 23, 2009. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Glustitch, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2009
Date Received
December 17, 2008
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 Glustitch, Inc.

  • K150032 — GluStitch Twist Tissue Adhesive (January 14, 2016)
  • K071484 — PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 (October 10, 2007)
  • K030574 — GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER (August 21, 2003)
  • K013446 — GLUSITE, MODEL GLU002 (December 20, 2001)

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