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Portascope II

by Mennen Greatbatch Electonics

510(k) K770832

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770832 Date3 Jun 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DPS
Device Class
Class II
Regulation
21 CFR Part 870.2340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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 Portascope II is a diagnostic ultrasound device designed for transesophageal echocardiography (TEE). It is classified under the product code DPS and is intended for imaging the heart and surrounding structures via an esophageal probe, providing real-time visualization for cardiovascular assessment.

This device is supplied as a reusable medical instrument and requires appropriate sterilization between uses. It was cleared under the FDA 510(k) pathway in 1977 (K770832) and falls under the Cardiovascular advisory committee review. No additional regulatory status beyond the stated FDA clearance is implied.

Other devices from Mennen Greatbatch Electonics

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 Portascope II used for in clinical practice?

    The Portascope II is specifically designed for transesophageal echocardiography (TEE), a procedure where an ultrasound probe is inserted into the esophagus to obtain detailed, real-time images of the heart and adjacent structures. This allows clinicians to assess cardiovascular function, detect abnormalities, and guide interventions with precise visualization.

  • How is the Portascope II supplied and prepared for use?

    The Portascope II is supplied as a reusable medical device. Before each use, it must undergo proper sterilization to ensure safety and hygiene. This means it is not single-use, and healthcare facilities must follow established protocols for cleaning and sterilizing the device between patients.

  • What regulatory pathway was followed for the FDA clearance of the Portascope II?

    The Portascope II was cleared through the FDA’s 510(k) pathway in 1977 under the product code DPS, with a clearance number of K770832. It was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device, as indicated by the decision code SESE.

  • Is the Portascope II compatible with all types of ultrasound imaging systems?

    The Portascope II is a standalone diagnostic ultrasound device specifically designed for transesophageal echocardiography (TEE). While it is not explicitly described as interchangeable with other imaging systems, its function is tied to the TEE probe and its integrated ultrasound capabilities, so it is intended to be used as a complete system for that purpose.