510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K014297Substantially Equivalent

Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P

Boston Scientific Corporation, Natick, MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014297 is the FDA 510(k) clearance record for ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P, a class II device, cleared for Boston Scientific Corp on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K014297.

Clearance record

Decision date
Received
(190 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary
Third party review
No

Clearances, product code KNT

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