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510(k) K011532

MITYVAC by Prism Enterprises, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2001
Date Received
May 18, 2001
Clearance Type
Special
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 Prism Enterprises, Inc.

  • K030283 — BABY POD (April 22, 2003)
  • K020447 — MITYVAC MERLIN, MODEL 10027 (April 12, 2002)
  • K000444 — MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM (April 21, 2000)

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)
  • 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)
  • K973942 — SWIFT DELIVERY PRODUCT #300 (December 12, 1997)