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510(k) K052365

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE by Rocket Medical Plc — Product Code HEE

K052365 is an FDA 510(k) premarket notification submitted by Rocket Medical Plc for the device "CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE". The FDA issued a decision of Substantially Equivalent on October 17, 2005. The device falls under product code HEE (Set, Anesthesia, Paracervical), a Class II device regulated under 21 CFR 884.5100. Rocket Medical Plc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2005
Date Received
August 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Anesthesia, Paracervical
Device Class
Class II
Regulation Number
884.5100
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)
  • K042264 — GUIDEWIRES (November 24, 2004)
  • K040189 — ENDOMETRIAL SAMPLING SYRINGE (October 4, 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 HEE

  • K021224 — ENDOCERVICAL BLOCK NEEDLE (July 12, 2002)
  • K000117 — AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE (April 13, 2000)
  • K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 3 (February 1, 1999)
  • K980238 — GYNEX EXTENDED REACH NEEDLE (August 21, 1998)
  • K973671 — ENDOCERVICAL BLOCK NEEDLE (November 26, 1997)
  • K954718 — ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE (February 29, 1996)
  • K910253 — LEEP REDIKIT (April 18, 1991)
  • K910252 — POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (March 4, 1991)

FDA data resources