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510(k) K140761

KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA by Carefusion 2200, Inc. — Product Code HES

K140761 is an FDA 510(k) premarket notification submitted by Carefusion 2200, Inc. for the device "KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA". The FDA issued a decision of Substantially Equivalent on April 21, 2014. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Carefusion 2200, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2014
Date Received
March 26, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
Device Class
Class II
Regulation Number
884.1300
Review Panel
OB
Submission Type

Other clearances by Carefusion 2200, Inc.

  • K210324 — V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV (March 4, 2021)
  • K163615 — Snowden-Pencer MicroLap 3mm Laparoscopic Instruments (May 4, 2017)
  • K162432 — Multi-Link X2 ECG Cable and Lead Wire System (January 18, 2017)
  • K160764 — AirLife Autofill Humidification Chamber (August 25, 2016)
  • K153554 — Genesis Low Temperature Reusable Rigid Container System (March 21, 2016)
  • K151036 — Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instrum (February 1, 2016)
  • K142529 — Genesis Reusable Rigid Container System (January 8, 2015)
  • K140850 — GENESIS REUSABLE RIGID CONTAINER SYSTEM (August 27, 2014)
  • K113407 — SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS (September 7, 2012)
  • K112535 — GENESIS REUSABLE RIGID CONTAINER SYSTEM (April 27, 2012)

Other clearances for product code HES

  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)
  • K903209 — MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER (December 21, 1990)
  • K903208 — MAXI-FLOW INSUFFLATOR TUBING SET (December 17, 1990)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K901413 — CORE DISPOSABLE INSUFFLATION TUBING (September 24, 1990)
  • K891290 — SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER (May 23, 1989)
  • K890869 — BARD HYSTEROSALPINGOGRAPHY CATHETERS (April 25, 1989)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K873515 — UTERINE INJECTOR 2MM (September 29, 1987)
  • K862310 — CABOT MEDICAL VARIABLE FLOW INSUFFLATOR (August 12, 1986)

FDA data resources