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510(k) K191264

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) by Ujenzi Charitable Trust — Product Code OQY

K191264 is an FDA 510(k) premarket notification submitted by Ujenzi Charitable Trust for the device "Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)". The FDA issued a decision of Substantially Equivalent on October 30, 2019. The device falls under product code OQY (Intrauterine Tamponade Balloon), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2019
Date Received
May 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intrauterine Tamponade Balloon
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

provides temporary control or reduction of postpartum uterine bleeding

Other clearances for product code OQY

  • K253642 — Jada System (Jada-2002) (May 15, 2026)
  • K230849 — ELLAVI UBT (November 13, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K212757 — Jada System (September 30, 2021)
  • K201199 — Jada System (August 28, 2020)
  • K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Compo (March 31, 2017)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K101535 — BT-CATH (January 11, 2011)
  • K091958 — BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (April 30, 2010)

FDA data resources