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Intestoplant

by Burron Medical Products, Inc.

510(k) K862412

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 NumberK862412 Date13 Nov 1986ClearedStatusActive

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  • Withdrawn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
LLD
Device Class
Class II
Regulation
21 CFR Part 880.5965
Advisory Committee
General Hospital
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 Intestoplant is a subcutaneous, intraperitoneal implanted port and catheter system designed for long-term access to the peritoneal cavity. It facilitates fluid administration, drainage, or diagnostic sampling in patients requiring repeated interventions, such as peritoneal dialysis or chemotherapy delivery.

This device is supplied sterile and intended for single-use implantation, though reuse may occur under controlled clinical conditions. It is classified under FDA regulation 880.5965 as a Class II medical device, with clearance granted under the 510(k) pathway (K862412) for general hospital use. No MRI safety information or specific size variants are documented in the available data.

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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 Intestoplant device used for?

    The Intestoplant is a subcutaneous, intraperitoneal implanted port and catheter system designed for long-term access to the peritoneal cavity, facilitating fluid administration, drainage, or diagnostic sampling in patients requiring repeated interventions like peritoneal dialysis or chemotherapy delivery.

  • Is the Intestoplant device supplied sterile?

    Yes, the Intestoplant is supplied sterile for single-use implantation, though reuse may occur under controlled clinical conditions as specified in the device description.

  • What is the regulatory classification of the Intestoplant device?

    The Intestoplant is classified under FDA regulation 880.5965 as a Class II medical device, with clearance granted under the 510(k) pathway (K862412) for general hospital use.

  • Are there different size variants available for the Intestoplant?

    No specific size variants are documented in the available data for the Intestoplant device.