Cleared Traditional

BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U (K022434) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022434 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Aug 2002
Decision
11d
Days
Class 2
Risk

K022434 is an FDA 510(k) clearance for the BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U. Classified as Ligator, Esophageal (product code MND), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on August 5, 2002 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4400 - 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 K022434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2002
Decision Date August 05, 2002
Days to Decision 11 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 130d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MND Ligator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
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 Consultant

N.V. Kema
PETER N RUYS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MND Ligator, Esophageal

All 14
Devices cleared under the same product code (MND) and FDA review panel - the closest regulatory comparables to K022434.
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · C.R. Bard, Inc. · Nov 2003
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K990864 · Boston Scientific Corp · Jun 1999
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
K971137 · C.R. Bard, Inc. · Oct 1997
STIEGMANN-GOFF ENDOSCOPIC LIGATOR
K940661 · C.R. Bard, Inc. · Nov 1994

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.