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FDA 510(k)

ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION

K-Number: K935617 · 1994-09-16

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date1994-09-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 1994-09-16 under 510(k) number K935617. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION?

ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION is a medical device that received FDA 510(k) clearance on 1994-09-16. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K935617.

When did ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION receive FDA 510(k) clearance?

ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION received FDA 510(k) clearance on 1994-09-16, under 510(k) number K935617.

Who is the listed applicant for ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION?

The FDA product code for ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION is HRX.

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Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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