Skip to content

Olympus PR-23Q Disposable Cannula (Ball Tip)

by Olympus America, Inc.

510(k) K950729

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK950729 Date17 Mar 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0969-2021 FDA Class II initiated 4 Jan 2021 on shared 510(k) K950729

    Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

This device is an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula, specifically designed for use in endoscopic procedures to access the biliary and pancreatic ducts. It is a disposable cannula featuring a ball tip, intended for selective cannulation during ERCP.

The device is supplied sterile and intended for single-use only. It is classified as a Class II medical device under regulation number 876.1500, with product code ODD, and received traditional 510(k) clearance (K950729) from the FDA on March 17, 1995, based on substantial equivalence to a predicate device. The clearance was reviewed by the Gastroenterology and Urology advisory committee.

Other devices from Olympus America, Inc.

See all devices from Olympus America, Inc. →

Questions

AI-generated answers, 21 Sep 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 OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) used for?

    This device is an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula designed for use in endoscopic procedures to access the biliary and pancreatic ducts. It features a ball tip and is intended for selective cannulation during ERCP, allowing physicians to navigate and catheterize the ducts for diagnostic or therapeutic interventions.

  • How is the OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) supplied and is it reusable?

    The device is supplied sterile and intended for single-use only. As a disposable cannula, it is not designed for cleaning, reprocessing, or reuse. Using it more than once could compromise sterility, structural integrity, and patient safety, which is why it is designated for one-time use during a single procedure.

  • What regulatory pathway was used for the OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)?

    The device received traditional 510(k) clearance from the FDA, identified by K950729, on March 17, 1995. It was found substantially equivalent to a predicate device and reviewed by the Gastroenterology and Urology advisory committee. This clearance pathway confirms its safety and effectiveness for the intended use in ERCP procedures.