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Gamma Steril Capillary Flow DIALY-G15

by Travenol Laboratories, S.A. 510(k)

Active United States

510(k) K832663

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832663 Date12 Sep 1983ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FKQ
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
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 Gamma Steril Capillary Flow Dialy-G15 is a System, Dialysate Delivery, Central Multiple Patient device, designed for continuous peritoneal dialysis. It delivers dialysate fluid through a capillary flow mechanism to facilitate the exchange of solutes and fluids across the peritoneal membrane, supporting renal replacement therapy in clinical settings.

This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance (K832663) under regulation 876.5820. It is classified as a Class II medical device and is intended for use in gastroenterology and urology procedures. The product code FKQ identifies it for regulatory tracking, and its design ensures compatibility with central multiple-patient dialysis systems.

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