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510(k) K862310

CABOT MEDICAL VARIABLE FLOW INSUFFLATOR by Cabot Medical Corp. — Product Code HES

K862310 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CABOT MEDICAL VARIABLE FLOW INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on August 12, 1986. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1986
Date Received
June 17, 1986
Clearance Type
Traditional
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 Cabot Medical Corp.

  • K960148 — CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT (March 25, 1996)
  • K946109 — CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS (November 21, 1995)
  • K951972 — CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SH (July 21, 1995)
  • K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (July 11, 1995)
  • K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (April 19, 1995)
  • K934115 — 3000 ELECTRONIC INSUFFLATOR MODIFICATION (March 15, 1995)
  • K932293 — CABOT MEDICAL BIPOLAR CUTTING FORCEPS (July 27, 1994)
  • K930954 — THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV (June 30, 1994)
  • K932626 — CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB (June 8, 1994)
  • K935786 — CORSON AND NEZHAT SUCTION/IRRIGATION PROBES (May 19, 1994)

Other clearances for product code HES

  • K140761 — KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA (April 21, 2014)
  • 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)

FDA data resources