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Endoscopic Catheter

by Act Medical, Inc.

510(k) K953967

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 NumberK953967 Date22 Jan 1996ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 22 Sep 2026

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

The Endoscopic Catheter is a Class II medical device classified as an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula. It is designed for use in gastroenterology and urology procedures, specifically for endoscopic applications.

This device is supplied by Act Medical, Inc. and is authorized under FDA 510(k) clearance K953967 with a product code ODD. It is regulated under number 876.1500 and was determined to be substantially equivalent on January 22, 1996.

Other devices from Act Medical, Inc.

Questions

AI-generated answers, 22 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 Endoscopic Catheter used for?

    The Endoscopic Catheter is designed for use in gastroenterology and urology procedures, specifically as an Endoscopic Retrograde Cholangiopancreatography (ERCP) Cannula for endoscopic applications.

  • What is the regulatory status of this device?

    This device is authorized under FDA 510(k) clearance K953967 with product code ODD. It was determined to be substantially equivalent on January 22, 1996, and is regulated under number 876.1500.

  • How is the Endoscopic Catheter supplied?

    The Endoscopic Catheter is supplied by Act Medical, Inc. The device is manufactured at their facility located at 100 Beaver St., Waltham, MA 02154, USA.

  • What specialties typically use this catheter?

    The Endoscopic Catheter is reviewed by the Gastroenterology, Urology (GU) advisory committee, indicating it is primarily intended for use by specialists in these medical fields.