PILLING ESOPHAGEAL BOUGIES— 510(k) K133439

Name: FDA 510(k) clearance K133439
Creator: U.S. Food and Drug Administration
Published: 2014-06-16

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K133439 for PILLING ESOPHAGEAL BOUGIES, Substantially Equivalent on 2014-06-16. Applicant: Teleflexmedical, Inc.. Device class: 2.

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code FAT
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 2013-11-12
Decision date: 2014-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAT

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K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT1999-06-04
K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)1998-02-02
K960173 — INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT1996-06-27
K901425 — PYLORIC BALLOON DILATOR1990-06-21
K843186 — ESKA MULTISTAGE ESOPHAGEAL BOUGIE1985-01-18

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Data sourced from openFDA. This site is unofficial and independent of the FDA.