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510(k) K052796

COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES by Valleylab — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2006
Date Received
October 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Valleylab

  • 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)
  • 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)
  • K031011 — LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 (May 29, 2003)

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