Home / 510(k) Clearances / K010053

510(k) K010053

HUMI-FLOW, MODEL 6-850-00/ 01/02 by Northgate Technologies, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2001
Date Received
January 8, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by Northgate Technologies, Inc.

  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System (March 25, 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)
  • 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 HIF

  • K250388 — ENDOFLATOR + (September 22, 2025)
  • K242772 — AirSurgN Insufflator (10030/AirSurgN) (April 11, 2025)
  • K243527 — High Flow Insufflation Unit (UHI-4) (January 13, 2025)
  • K242536 — TauTona Pneumoperitoneum Assist Device (TPAD) (October 15, 2024)
  • K232464 — VereSee Optical Veres Needle System (May 2, 2024)
  • K232902 — EVA15 insufflator (May 2, 2024)
  • K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) (January 12, 2024)
  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)