510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OQYClass II

Intrauterine Tamponade Balloon

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

OQY is the FDA product code for Intrauterine Tamponade Balloon, a class II device type, regulated under 21 CFR 884.4530. FDA's definition for this code reads: "provides temporary control or reduction of postpartum uterine bleeding". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OQY
Device name
Intrauterine Tamponade Balloon
FDA definition
provides temporary control or reduction of postpartum uterine bleeding
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
2

Clearances, product code OQY

By decision year
11 clearances under product code OQY with a decision year between 2010 and 2026, 2010 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OQY by decision year
YearClearances
20101
20111
20151
20161
20171
20191
20201
20211
20221
20231
20261

Applicants with the most clearances

Product code OQY
Applicants holding the most 510(k) clearances under product code OQY
ApplicantClearances
Alydia Health2
Clinical Innovations, LLC2
Cook Incorporated2
Glenveigh Surgical, LLC1
Organon LLC1
Sinapi Biomedical (Pty) Ltd1
Ujenzi Charitable Trust1
Utah Medical Products, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code