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510(k) K000340

HYSTALOG HSG CATHETER by Rocket Medical Plc — Product Code HES

K000340 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "HYSTALOG HSG CATHETER". The FDA issued a decision of Substantially Equivalent on April 19, 2000. The device falls under product code HES (Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)), a Class II device regulated under 21 CFR 884.1300. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2000
Date Received
February 3, 2000
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 Rocket Medical Plc

  • K210509 — Rocket Platinum Cured Cathter (September 9, 2021)
  • K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (August 17, 2017)
  • K162457 — Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit (November 14, 2016)
  • K152105 — Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set (March 29, 2016)
  • K123033 — ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PA (February 1, 2013)
  • K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE (October 17, 2005)
  • K042264 — GUIDEWIRES (November 24, 2004)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 2004)
  • K032015 — EMBRYON ULTRASOUND NEEDLE GUIDE (August 8, 2003)
  • K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (April 19, 2000)

Other clearances for product code HES

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