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510(k) K040189

ENDOMETRIAL SAMPLING SYRINGE by Rocket Medical Plc — Product Code HHK

K040189 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "ENDOMETRIAL SAMPLING SYRINGE". The FDA issued a decision of Substantially Equivalent on October 4, 2004. The device falls under product code HHK (Curette, Suction, Endometrial (And Accessories)), a Class II device regulated under 21 CFR 884.1175. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2004
Date Received
January 28, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Suction, Endometrial (And Accessories)
Device Class
Class II
Regulation Number
884.1175
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)
  • K032015 — EMBRYON ULTRASOUND NEEDLE GUIDE (August 8, 2003)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)
  • K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (April 19, 2000)

Other clearances for product code HHK

  • K251882 — Uterine Aspiration Set (October 16, 2025)
  • K240434 — RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) (September 25, 2024)
  • K201952 — CrossGlide ETS Plus (August 5, 2020)
  • K192534 — CrossBay Endometrial Tissue Sampler (ETS) (March 25, 2020)
  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)
  • K092982 — THE PANPAC SUCTION CURETTE (July 26, 2010)
  • K051294 — FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 (December 21, 2005)
  • K021876 — MAS WITH OR WITHOUT SYRINGE (April 8, 2003)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)

FDA data resources