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FDA 510(k)

SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS

K-Number: K981286 · 1998-06-19

ApplicantArmm, Inc.
Decision Date1998-06-19
Product CodeKDH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS is the device name listed in this FDA 510(k) record. The listed applicant is Armm, Inc.. It received FDA 510(k) clearance on 1998-06-19 under 510(k) number K981286. The device is classified under product code KDH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS?

SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS is a medical device that received FDA 510(k) clearance on 1998-06-19. The listed applicant is Armm, Inc.. The 510(k) number is K981286.

When did SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS receive FDA 510(k) clearance?

SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS received FDA 510(k) clearance on 1998-06-19, under 510(k) number K981286.

Who is the listed applicant for SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS?

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

What is the FDA product code for SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS?

The FDA product code for SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS is KDH.

Related Clinical Trials

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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Other records listing Armm, 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.

K923201ENDOSI SUCTION IRRIGATORK922245SUPER-FLOW TUBINGK931607MEDDRAINS

Related Devices (Code: KDH)

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.

K983624GILTECH PLUS CONNECTING TUBE SETGiltech Plus, Inc.K971259COMBIPORT FLUID LAVAGE DEVICEB.Braun Medical, Inc.K962850TUM-E-VACEthox Corp.K951533EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KITBallard Medical ProductsK923497FLUSHING IRRIGATION SETOrion Life Systems, Inc.K920619TRI-MED GASTRIC LAVAGE SYSTEMTri-Med Specialties, Inc.

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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