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510(k) K230849

ELLAVI UBT by Sinapi Biomedical (Pty) , Ltd. — Product Code OQY

K230849 is an FDA 510(k) premarket notification submitted by Sinapi Biomedical (Pty) , Ltd. for the device "ELLAVI UBT". The FDA issued a decision of Substantially Equivalent on November 13, 2023. 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
November 13, 2023
Date Received
March 28, 2023
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)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K212757 — Jada System (September 30, 2021)
  • K201199 — Jada System (August 28, 2020)
  • K191264 — Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (October 30, 2019)
  • 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