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510(k) K904026

INFLAT-O-BALL by Milex Products, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1990
Date Received
August 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

Other clearances by Milex Products, Inc.

  • K001545 — PIPET CURET (June 15, 2000)
  • K904774 — INGLAT-O-BALL (December 7, 1990)
  • K900903 — KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE (May 3, 1990)
  • K882628 — ENDO C BRUSH (July 25, 1988)
  • K862410 — MILEX KEGEL PERINEAL EXERCISER (July 31, 1986)
  • K861385 — MILEX BARTHOLIN GLAND CATHETER (June 16, 1986)
  • K760264 — CURETTE, PROPOSED TIS-U-TRAP, METAL (October 6, 1976)

Other clearances for product code HHW

  • K253698 — Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Supp (January 20, 2026)
  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • K240798 — Cntrl+ Bladder Support Pessary (December 17, 2024)
  • K232677 — Reia pessary (May 21, 2024)
  • K232525 — Yoni.Fit Bladder Support (May 17, 2024)
  • K233548 — Uresta® (April 3, 2024)
  • K231786 — Gynethotics™ Pessary (March 6, 2024)
  • K190277 — ProVate Vaginal Support (July 8, 2019)
  • K183468 — Revive Reusable Bladder Support (January 25, 2019)
  • K173351 — Panpac Flexi Shelf Pessary (October 31, 2018)