Home / 510(k) Clearances / K913324

510(k) K913324

MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT by Neward Enterprises, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1992
Date Received
July 25, 1991
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 Neward Enterprises, Inc.

  • K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE (August 29, 1996)
  • K943938 — MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE (May 3, 1995)
  • K934011 — MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE (May 4, 1994)
  • K925572 — MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE (October 8, 1993)
  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
  • K890307 — MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE (March 31, 1989)
  • K840403 — VENA * BRIDGE (March 12, 1984)

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)