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510(k) K912612

SMOKE/ODOR EVACUATOR #757 by Olsen Electrosurgical, Inc. — Product Code FYD

K912612 is an FDA 510(k) premarket notification submitted by Olsen Electrosurgical, Inc. for the device "SMOKE/ODOR EVACUATOR #757". The FDA issued a decision of Substantially Equivalent on November 1, 1991. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Olsen Electrosurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1991
Date Received
June 12, 1991
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 Olsen Electrosurgical, Inc.

  • K922154 — INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION (April 21, 1994)
  • K912611 — OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE (April 15, 1992)
  • K913108 — TEFLON COATED ELECTRODES/ELECTRODES HANDLES (December 23, 1991)
  • K885199 — #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES (January 13, 1989)
  • K885200 — 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE (January 13, 1989)
  • K884172 — MODIFIED OLSEN #770 DISPOSABLE HOLSTER (October 24, 1988)
  • K884173 — #920 DISPOSABLE TUR CABLE (October 24, 1988)
  • K884171 — #875 DISPOSABLE BIOPOLAR CABLE (October 24, 1988)
  • K884174 — MODIFIED OLSEN 755/756 SWITCHPENS (October 24, 1988)
  • K884175 — #820/821 BIPOLAR FORCEPS (October 24, 1988)

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