Home / 510(k) Clearances / K000394

510(k) K000394

CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT by Rocket Medical Plc — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2000
Date Received
February 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
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 MQG

  • K242684 — Harioculture TL-16 Time-lapse Incubator (May 22, 2025)
  • K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (May 7, 2024)
  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K160504 — RI Witness Embryology Heated Plate (July 18, 2016)
  • K151357 — MIRI TL (April 22, 2016)
  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)