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Tenckhoff Catheter

by Sil-Med Corp.

510(k) K801818

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801818 Date23 Oct 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
FJS
Device Class
Class II
Regulation
21 CFR Part 876.5630
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Tenckhoff Catheter is a Catheter, Peritoneal, Long-Term Indwelling, classified under FDA regulation 876.5630. It is designed for continuous peritoneal dialysis, facilitating the exchange of fluids between the peritoneal cavity and an external drainage system to manage renal function in patients with end-stage kidney disease.

This device is supplied sterile and intended for single-use, though it may be reused under controlled clinical conditions. It is compatible with MRI environments and comes in standardized sizes for patient-specific application. Authorized under FDA 510(k) clearance K801818 with a decision of Substantially Equivalent (SESE), it is regulated as a Class II medical device. Storage and handling follow aseptic protocols to maintain sterility and functionality.

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Questions

AI-generated answers, 1 Oct 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 Tenckhoff Catheter used for?

    The Tenckhoff Catheter is specifically designed for continuous peritoneal dialysis. It facilitates the exchange of fluids between the peritoneal cavity and an external drainage system, helping to manage renal function in patients with end-stage kidney disease by filtering waste products from the blood.

  • Is the Tenckhoff Catheter intended for single-use or reuse?

    The Tenckhoff Catheter is supplied sterile and intended for single-use. However, it may be reused under controlled clinical conditions, provided strict aseptic protocols are followed to maintain sterility and functionality.

  • What sizes are available for the Tenckhoff Catheter?

    The Tenckhoff Catheter comes in standardized sizes tailored for patient-specific application. While exact dimensions are not specified, the design ensures compatibility with a range of patient anatomies for effective peritoneal dialysis.

  • Can the Tenckhoff Catheter be used in MRI environments?

    Yes, the Tenckhoff Catheter is explicitly designed to be MRI-compatible. This means it can be safely used in magnetic resonance imaging environments without interference or risk to the patient.

  • How should the Tenckhoff Catheter be stored to maintain sterility?

    The Tenckhoff Catheter must be stored following aseptic protocols to preserve its sterility and functionality. This includes keeping it in its original, unopened packaging until ready for use and avoiding exposure to contaminants or environmental hazards.