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510(k) K223098

Bakri Essential Postpartum Balloon by Cook Incorporated — Product Code OQY

K223098 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Bakri Essential Postpartum Balloon". The FDA issued a decision of Substantially Equivalent on October 28, 2022. The device falls under product code OQY (Intrauterine Tamponade Balloon), a Class II device regulated under 21 CFR 884.4530. Cook Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
September 30, 2022
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 Cook Incorporated

  • K233177 — Nest VT Vitrification Device (March 8, 2024)
  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K210734 — Endovascular Dilator and Sets (April 6, 2021)
  • K203670 — Extra Large Check-Flo Introducer (February 16, 2021)
  • K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrath (January 29, 2020)
  • K190903 — Lawson Retrograde Nephrostomy Wire Puncture Set (December 16, 2019)
  • K191163 — Lumax Guiding Catheter (December 12, 2019)
  • K193133 — Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Mult (December 12, 2019)
  • K190084 — McLean-Ring Enteral Feeding Tube Set (October 11, 2019)
  • K183323 — UPJ Occlusion Balloon Catheter (August 5, 2019)

Other clearances for product code OQY

  • K253642 — Jada System (Jada-2002) (May 15, 2026)
  • K230849 — ELLAVI UBT (November 13, 2023)
  • 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