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510(k) K980915

VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM by Valleylab, Inc. — Product Code FYD

K980915 is an FDA 510(k) premarket notification submitted by Valleylab, Inc. for the device "VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on June 29, 1998. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Valleylab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1998
Date Received
March 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
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)

Other clearances for product code FYD

  • K240127 — PlumeSafe X5 Smoke Management System (August 5, 2024)
  • K233789 — 8Q10 Surclear Smoke Plume Evacuation System (April 10, 2024)
  • K213068 — Medline Smoke Evacuation Shroud (January 3, 2022)
  • K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System (March 25, 2021)
  • K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect (June 26, 2020)
  • K192035 — EvaQMax Smoke Evacuation System (August 29, 2019)
  • K191328 — Megadyne Foot Switch (July 26, 2019)
  • K182224 — SafeAir Smoke Evacuator compact (February 7, 2019)
  • K173108 — Smoklean (May 18, 2018)
  • K163659 — Crystal Vision (October 30, 2017)

FDA data resources