Home / 510(k) Clearances / K840008

510(k) K840008

O'NEIL OBSTETRIC CUP by Go Medical Industries Pty. , Ltd. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
January 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type

Other clearances by Go Medical Industries Pty. , Ltd.

  • K011055 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS (June 6, 2001)
  • K002803 — THE O'NEIL STERILE FIELD URINARY CATHETER KIT (December 27, 2000)
  • K000263 — GO MEDICAL BALLOON INFUSION SYSTEM (May 9, 2000)
  • K910007 — SPRINGFUSOR 10R (November 2, 1993)
  • K900336 — V SET (October 4, 1990)
  • K895594 — SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE (October 6, 1989)
  • K890400 — MODIFIED URINARY CATHETER INTRODUCER (UCI) (September 12, 1989)
  • K891465 — OBSTETRIC CUP (MODIFICATION) (May 11, 1989)
  • K885283 — ASPIRATING AND IRRIGATING CYSTS NEEDLES (March 22, 1989)
  • K850758 — AMNIGLOVE & AMNICOT (April 15, 1985)

Other clearances for product code HDB

  • K250298 — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vac (October 8, 2025)
  • K041579 — MEDELA SINGLE USE SILC CUP, MODEL 077.0791 (April 21, 2005)
  • K043614 — VACULINK, MODEL VCL 3000 (April 14, 2005)
  • K021193 — FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (February 12, 2003)
  • K020447 — MITYVAC MERLIN, MODEL 10027 (April 12, 2002)
  • K013460 — SWIFT LOW PROFILE CUP (PRO CUP) (January 17, 2002)
  • K011532 — MITYVAC (July 30, 2001)
  • K981260 — KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM (September 22, 1998)
  • K980976 — AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (August 21, 1998)
  • K980212 — MITYVAC (July 9, 1998)