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
SUBSCRIBE / SIGN IN
K092144Substantially Equivalent

Bonastent Esophageal, Models Be and Ber, Bonastent Esophageal U.e.s. Flange and Flare, Models Befg and Befr

Boston Scientific Corporation, Chalotte NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092144 is the FDA 510(k) clearance record for BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR, a class II device, cleared for Endochoice, Inc. on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K092144.

Clearance record

Decision date
Received
(222 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Endochoice, Inc. 1914 J.N. Pease Pl., Chalotte NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ESW

Trailing 12 months
1 clearance under product code ESW 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 ESW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260