Cleared Traditional

K133439 - PILLING ESOPHAGEAL BOUGIES

K133439 is an FDA 510(k) clearance for PILLING ESOPHAGEAL BOUGIES, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAT cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K133439 · Teleflexmedical, Inc. · Gastroenterology & Urology device
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Jun 2014
Decision
216d
Days
Class 2
Risk

K133439 is an FDA 510(k) clearance for the PILLING ESOPHAGEAL BOUGIES. Classified as Bougie, Esophageal, And Gastrointestinal, Gastro-urology (product code FAT), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on June 16, 2014 after a review of 216 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K133439

510(k) Number K133439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2013
Decision Date June 16, 2014
Days to Decision 216 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 131d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAT Device Classification - Class 2, Special Controls

Product Code FAT Bougie, Esophageal, And Gastrointestinal, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAT Bougie, Esophageal, And Gastrointestinal, Gastro-urology

All 7
Devices cleared under the same product code (FAT) and FDA review panel - the closest regulatory comparables to K133439.
STRYKER INFRAVISION ESOPHAGEAL KIT
K983220 · Stryker Endoscopy · Jun 1999
MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
K972119 · Medovations, Inc. · Feb 1998
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
K960173 · Gabriel Medical, Inc. · Jun 1996
PYLORIC BALLOON DILATOR
K901425 · Telemed Systems, Inc. · Jun 1990
ESKA MULTISTAGE ESOPHAGEAL BOUGIE
K843186 · Dacomed Corp. · Jan 1985
ESOPHAGEAL DILATOR SET
K842679 · Mill-Rose Laboratory · Oct 1984