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510(k) K890021

STERILE POLYHESIVE PBS DRESSING by Valleylab, Inc. — Product Code KGF

K890021 is an FDA 510(k) premarket notification submitted by Valleylab, Inc. for the device "STERILE POLYHESIVE PBS DRESSING". The FDA issued a decision of SN on June 1, 1989. The device falls under product code KGF (Adhesive, Tissue For Aneurysmorrhaphy), a Class III device. Valleylab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
June 1, 1989
Date Received
January 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Tissue For Aneurysmorrhaphy
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

Other clearances by Valleylab, Inc.

  • K092879 — LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER (October 16, 2009)
  • K063195 — LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS L (November 29, 2006)
  • K053535 — VIVAWAVE MICROWAVE ABLATION SYSTEM (April 27, 2006)
  • K053290 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (March 15, 2006)
  • K052796 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES (February 3, 2006)
  • K051644 — VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR (August 11, 2005)
  • K051627 — VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT (July 22, 2005)
  • K043273 — LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS (January 5, 2005)
  • K042216 — COOL-TIP RF ABLATION SYSTEM (November 12, 2004)
  • K041587 — LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # (September 28, 2004)

FDA data resources