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FDA 510(k)

ARTHRO-FLOW IRRIGATION 2 SYSTEM

K-Number: K913028 · 1991-10-10

ApplicantDavol, Inc.
Decision Date1991-10-10
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHRO-FLOW IRRIGATION 2 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1991-10-10 under 510(k) number K913028. 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-FLOW IRRIGATION 2 SYSTEM?

ARTHRO-FLOW IRRIGATION 2 SYSTEM is a medical device that received FDA 510(k) clearance on 1991-10-10. The listed applicant is Davol, Inc.. The 510(k) number is K913028.

When did ARTHRO-FLOW IRRIGATION 2 SYSTEM receive FDA 510(k) clearance?

ARTHRO-FLOW IRRIGATION 2 SYSTEM received FDA 510(k) clearance on 1991-10-10, under 510(k) number K913028.

Who is the listed applicant for ARTHRO-FLOW IRRIGATION 2 SYSTEM?

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

What is the FDA product code for ARTHRO-FLOW IRRIGATION 2 SYSTEM?

The FDA product code for ARTHRO-FLOW IRRIGATION 2 SYSTEM is HRX.

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Other records listing Davol, Inc. as applicant

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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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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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