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Doscope and Accessories

by Applied Laparoscopy

510(k) K920224

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)SESK Substantially Equivalent — Kit · Traditional NumberK920224 Date21 Aug 1992ClearedStatusActive

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  • Withdrawn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)

Full name
Doscope and Acessories
510(k) Number
FDA Product Code
FBN
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 19 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 Doscope and Accessories is a Choledochoscope and Accessories, Flexible/Rigid, a diagnostic device used for visual inspection of the biliary tree and pancreatic ducts. It facilitates direct visualization of the common bile duct, pancreatic duct, and associated structures to identify obstructions, strictures, or abnormalities during endoscopic procedures.

This device is supplied as a kit and is intended for single-use in controlled clinical settings such as endoscopy suites. It is classified as a Class II medical device under FDA regulation 876.1500, with a 510(k) clearance (K920224) granted in 1992. The accessories include components compatible with flexible and rigid choledochoscopes, ensuring compatibility with standard endoscopic procedures in gastroenterology and urology.

Other devices from Applied Laparoscopy

Questions

AI-generated answers, 19 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 primary clinical purpose of the Doscope and Accessories, and which medical specialties commonly use it?

    The Doscope and Accessories is designed for direct visualization of the biliary tree and pancreatic ducts during endoscopic procedures. It helps identify obstructions, strictures, or abnormalities in the common bile duct and associated structures. The device is primarily used in gastroenterology and urology, as indicated by the advisory committee and medical specialty descriptions in its regulatory filing.

  • Is the Doscope and Accessories intended for single-use or reusable applications, and how is it supplied?

    The Doscope and Accessories is intended for single-use only in controlled clinical settings like endoscopy suites. It is supplied as a kit, ensuring compatibility with both flexible and rigid choledochoscopes for standard endoscopic procedures in gastroenterology and urology.

  • What regulatory pathway was followed for FDA clearance of this device, and when was it originally approved?

    The Doscope and Accessories received FDA 510(k) clearance under the traditional review pathway, with the decision dated August 21, 1992. The clearance number is K920224, and it falls under FDA regulation 876.1500 as a Class II device.

  • Are there multiple models or sizes available for the Doscope and Accessories, and how would a clinician determine compatibility?

    While the provided data lists multiple FEI numbers (e.g., 3003782610, 3038296436), these are registration identifiers rather than explicit size or model designations. The kit is designed to be compatible with both flexible and rigid choledochoscopes, ensuring versatility for standard endoscopic procedures in gastroenterology and urology. Clinicians should confirm compatibility with their existing endoscopic equipment before use.