FDA 510(k)

AIR WATER SOURCE (ACMI MODEL 710)

K-Number: K760451 · 1976-08-30

ApplicantAmerican Cystocope Makers, Inc.

Decision Date1976-08-30

Product CodeOCX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AIR WATER SOURCE (ACMI MODEL 710) is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1976-08-30 under 510(k) number K760451. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR WATER SOURCE (ACMI MODEL 710)?

AIR WATER SOURCE (ACMI MODEL 710) is a medical device that received FDA 510(k) clearance on 1976-08-30. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K760451.

When did AIR WATER SOURCE (ACMI MODEL 710) receive FDA 510(k) clearance?

AIR WATER SOURCE (ACMI MODEL 710) received FDA 510(k) clearance on 1976-08-30, under 510(k) number K760451.

Who is the listed applicant for AIR WATER SOURCE (ACMI MODEL 710)?

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

What is the FDA product code for AIR WATER SOURCE (ACMI MODEL 710)?

The FDA product code for AIR WATER SOURCE (ACMI MODEL 710) is OCX.

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Other records listing American Cystocope Makers, Inc. as applicant

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Related Devices (Code: OCX)

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems Corporation K251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems Corporation K241874Aspiration Catheter (2189)Hobbs Medical, 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.