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Arthro-Flo Irrigation System Modification

by Davol Inc., Sub. C. R. Bard, Inc. 510(k)

Active United States

510(k) K935617

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935617 Date16 Sep 1994ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HRX
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Arthro-Flo Irrigation System Modification is a device used in orthopedic procedures for irrigation purposes. It is a modified version of the Arthro-Flo Irrigation System, designed to deliver fluid during surgical interventions.

This device is supplied by Davol Inc., Sub. C. R. Bard, Inc., and has received FDA 510(k) clearance under K935617. It is intended for use in clinical settings as a substantially equivalent device to a legally marketed predicate, with no claims made regarding sterility, single-use or reusable status, MRI safety, sizes, storage conditions, or additional authorisations beyond the FDA 510(k) clearance.

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