510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093904Substantially Equivalent

Glenveigh Vaginal Tamponade Balloon Catheter

Glenveigh Surgical, LLC, Swanee GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093904 is the FDA 510(k) clearance record for GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER, a class II device, cleared for Glenveigh Surgical, LLC on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list 2 510(k) clearances for Glenveigh Surgical, LLC, from to . As of , FDA records show no recalls naming K093904.

Clearance record

Decision date
Received
(113 days to decision)
Product code
KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Glenveigh Surgical, LLC 717 Lakeglen Dr., Swanee GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNA

Trailing 12 months

FDA records hold no clearances under product code KNA in the trailing twelve months.

FDA records show no clearances under product code KNA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260