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510(k) K153591

ebb Complete Tamponade System by Clinical Innovations, LLC — Product Code OQY

K153591 is an FDA 510(k) premarket notification submitted by Clinical Innovations, LLC for the device "ebb Complete Tamponade System". The FDA issued a decision of Substantially Equivalent on January 14, 2016. The device falls under product code OQY (Intrauterine Tamponade Balloon), a Class II device regulated under 21 CFR 884.4530. Clinical Innovations, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2016
Date Received
December 16, 2015
Clearance Type
Special
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 by Clinical Innovations, LLC

  • K250298 — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vac (October 8, 2025)
  • K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E) (May 22, 2025)
  • K223900 — babyLance Safety Heelstick (BLM, BLN, BLP) (February 24, 2023)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K140163 — KOALA TOCO (May 29, 2014)
  • K131781 — CLEARVIEW TOTAL (May 28, 2014)
  • K110605 — ROM PLUS (November 23, 2011)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)
  • K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000 (September 17, 2003)
  • K022023 — COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSUR (January 7, 2003)

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)
  • 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)
  • 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