510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860991Substantially Equivalent

Sclerotherapy Injection Catheter

Endovations, Camp Hill PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860991 is the FDA 510(k) clearance record for SCLEROTHERAPY INJECTION CATHETER, a class II device, cleared for Endovations on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 38 510(k) clearances for Endovations, from to . As of , FDA records show no recalls naming K860991.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endovations 895 Poplar Church Rd., Camp Hill PA
Third party review
No

Clearances, product code KNT

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