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Davol ERCP Cannula

by C. R. Bard, Inc.

510(k) K845018

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK845018 Date15 Jan 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ODD
FDA applicant
C.R. Bard, Inc.
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Davol ERCP Cannula is a Class II medical device classified as an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula. It is designed for use in endoscopic procedures to access the biliary and pancreatic ducts. The device is manufactured by C.R. Bard, Inc. and is intended for diagnostic and therapeutic gastrointestinal procedures.

The Davol ERCP Cannula is supplied as a single-use device and is regulated under FDA 510(k) clearance with product code ODD. It received FDA clearance on January 15, 1985, and is classified under regulation number 876.1500. The device is intended for use in gastroenterology and urology specialties and is stored according to manufacturer specifications.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DAVOL ERCP Cannula used for?

    The DAVOL ERCP Cannula is designed for use in endoscopic procedures to access the biliary and pancreatic ducts. It is intended for diagnostic and therapeutic gastrointestinal procedures in gastroenterology and urology specialties.

  • Is the DAVOL ERCP Cannula single-use or reusable?

    The DAVOL ERCP Cannula is supplied as a single-use device. It is not intended to be reused on multiple patients and should be discarded after a single procedure according to medical waste disposal protocols.

  • What is the regulatory status of the DAVOL ERCP Cannula?

    The DAVOL ERCP Cannula is a Class II medical device that received FDA 510(k) clearance on January 15, 1985, with product code ODD. It is classified under regulation number 876.1500 and is manufactured by C.R. Bard, Inc.

  • How should the DAVOL ERCP Cannula be stored?

    The DAVOL ERCP Cannula should be stored according to the manufacturer's specifications. While the exact storage conditions aren't detailed in the provided information, medical devices of this type typically require storage in a clean, dry environment at room temperature, away from direct sunlight and extreme temperatures.