Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component— 510(k) K170622

Name: FDA 510(k) clearance K170622
Creator: U.S. Food and Drug Administration
Published: 2017-03-31

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K170622 for Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component, Substantially Equivalent on 2017-03-31. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code OQY
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2017-03-01
Decision date: 2017-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OQY

view all

K253642 — Jada System (Jada-2002)2026-05-15
K230849 — ELLAVI UBT2023-11-13
K223098 — Bakri Essential Postpartum Balloon2022-10-28
K212757 — Jada System2021-09-30
K201199 — Jada System2020-08-28

More clearances from Cook Incorporated

view all

K233177 — Nest VT Vitrification Device2024-03-08
K222254 — Gunther Tulip Vena Cava Filter Retrieval Set2023-05-16
K210734 — Endovascular Dilator and Sets2021-04-06
K203670 — Extra Large Check-Flo Introducer2021-02-16
K191498 — Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc2020-01-29

Adverse events under product code OQY

product code OQY

Death: 8
Injury: 616
Malfunction: 500
Total: 1,124

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.