510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230849Substantially Equivalent

Ellavi Ubt

Sinapi Biomedical (Pty) Ltd, Stellenbosch, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230849 is the FDA 510(k) clearance record for ELLAVI UBT, a class II device, cleared for Sinapi Biomedical (Pty) , Ltd. on under FDA product code OQY (Intrauterine Tamponade Balloon). FDA's definition for product code OQY reads: "provides temporary control or reduction of postpartum uterine bleeding". FDA records list one 510(k) clearance for Sinapi Biomedical (Pty) , Ltd. As of , FDA records show no recalls naming K230849.

Clearance record

Decision date
Received
(230 days to decision)
Product code
OQY Intrauterine Tamponade Balloon
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Sinapi Biomedical (Pty) , Ltd. 1 Lelie Rd., Stellenbosch, ZA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQY

Trailing 12 months
1 clearance under product code OQY in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OQY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260