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FDA 510(k)

SURESEAL ENDOSCOPIC VALVE

K-Number: K920030 · 1992-03-18

ApplicantApplied Urology, Inc.
Decision Date1992-03-18
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SURESEAL ENDOSCOPIC VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Applied Urology, Inc.. It received FDA 510(k) clearance on 1992-03-18 under 510(k) number K920030. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESEAL ENDOSCOPIC VALVE?

SURESEAL ENDOSCOPIC VALVE is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is Applied Urology, Inc.. The 510(k) number is K920030.

When did SURESEAL ENDOSCOPIC VALVE receive FDA 510(k) clearance?

SURESEAL ENDOSCOPIC VALVE received FDA 510(k) clearance on 1992-03-18, under 510(k) number K920030.

Who is the listed applicant for SURESEAL ENDOSCOPIC VALVE?

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

What is the FDA product code for SURESEAL ENDOSCOPIC VALVE?

The FDA product code for SURESEAL ENDOSCOPIC VALVE is ODC.

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Other records listing Applied Urology, 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.

K921838ACUCISE URETERAL CUTTING CATHETERK925282UROLOGICAL CATHETER AND ACCESSORIESK920695URETERAL STENTK915219URETHRAL ELECTRODE SHEATHK912093DISPOSABLE ASPIRATION IRRIGATION SYSTEMK912656ENDOSCOPIC ELECTRODE

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Related Devices (Code: ODC)

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.

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston ScientificK250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems CorporationK250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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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