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510(k) K901413

CORE DISPOSABLE INSUFFLATION TUBING by Core Dynamics, Inc. — Product Code HES

K901413 is an FDA 510(k) premarket notification submitted by Core Dynamics, Inc. for the device "CORE DISPOSABLE INSUFFLATION TUBING". The FDA issued a decision of Substantially Equivalent on September 24, 1990. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Core Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1990
Date Received
March 26, 1990
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 Core Dynamics, Inc.

  • K992250 — CORE AUDIBLE TROCAR II (September 24, 1999)
  • K992190 — CORE POUCH (September 1, 1999)
  • K955490 — LAPAROSCOPIC KNITTER (January 22, 1996)
  • K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM (October 20, 1995)
  • K953409 — LAPAROSCOPIC TROCAR (October 16, 1995)
  • K950457 — CANNUAL AND TROCAR, SUPERPUBIC (May 5, 1995)
  • K943172 — CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR (July 28, 1994)
  • K935826 — LAPAROSCOPIC/SUCTION/IRRIGATION PROBE (May 18, 1994)
  • K932118 — ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET (March 17, 1994)
  • K932021 — ENTREE CANNULA FASCIA ANCHORS (January 11, 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)
  • 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