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510(k) K202944

NEBULAE SRS Laparoscopic Surgical Smoke Removal System by Northgate Technologies, Inc. — Product Code FYD

K202944 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "NEBULAE SRS Laparoscopic Surgical Smoke Removal System". The FDA issued a decision of Substantially Equivalent on March 25, 2021. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2021
Date Received
September 30, 2020
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 Northgate Technologies, Inc.

  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K130368 — AUTOLITH TOUCH; URO TOUCH (November 15, 2013)
  • K120151 — NEBULAE I (August 17, 2012)
  • K041560 — FLO-ASSISTANT (September 28, 2004)
  • K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/0 (July 29, 2004)
  • K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 (January 24, 2003)
  • K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02 (October 23, 2001)
  • K011928 — HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 (August 10, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)
  • K993778 — HYDROTOWER MANAGEMENT SYSTEM, MODEL 4-750-00 (January 6, 2000)

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)
  • 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)
  • K142335 — RapidVac Smoke Evacuator System (January 14, 2015)

FDA data resources