Cleared Traditional

K942044 - BARD ENDOSCOPIC OVERTUBE

K942044 is the FDA 510(k) clearance for BARD ENDOSCOPIC OVERTUBE by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FED) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K942044 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
43d
Days
Class 2
Risk

K942044 is an FDA 510(k) clearance for the BARD ENDOSCOPIC OVERTUBE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K942044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date June 10, 1994
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 62
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K942044.
URETERAL ACCESS SHEATH SET - NEW MODELS
K993650 · Applied Medical Resources · Dec 1999
URETERAL ACCESS SHEATH SET
K990775 · Applied Medical Resources · Apr 1999
BARD ENDOSCOPIC OVERTUBE (#000307)
K973500 · C.R. Bard, Inc. · Oct 1997
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
K921120 · Cook Urological, Inc. · Aug 1992
ST-E1 OVERTUBE
K903842 · Olympus Corp. · Jan 1991
ENDOSCOPIC OVERTUBE
K833268 · Mill-Rose Laboratory · Oct 1983