510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K880497Substantially Equivalent

Word Bartholin Gland Catheter Code: 1005

Hoosier Specialties, Inc., Sullivan IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880497 is the FDA 510(k) clearance record for WORD BARTHOLIN GLAND CATHETER CODE: 1005, a class II device, cleared for Hoosier Specialties, Inc. on under FDA product code KNA (Instrument, Manual, Specialized Obstetric-Gynecologic). FDA records list one 510(k) clearance for Hoosier Specialties, Inc. As of , FDA records show no recalls naming K880497.

Clearance record

Decision date
Received
(48 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
Hoosier Specialties, Inc. Rural Rte. #5, Sullivan IN
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