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FDA 510(k)

OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)

K-Number: K950729 · 1995-03-17

ApplicantOlympus America, Inc.
Decision Date1995-03-17
Product CodeODD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1995-03-17 under 510(k) number K950729. The device is classified under product code ODD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)?

OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) is a medical device that received FDA 510(k) clearance on 1995-03-17. The listed applicant is Olympus America, Inc.. The 510(k) number is K950729.

When did OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) receive FDA 510(k) clearance?

OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) received FDA 510(k) clearance on 1995-03-17, under 510(k) number K950729.

Who is the listed applicant for OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)?

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

What is the FDA product code for OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)?

The FDA product code for OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) is ODD.

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Other records listing Olympus America, Inc. as applicant

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K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: ODD)

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.

K250573Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614MOlympus Medical Systems Corp.K202583BioShield biopsy valve EUS - LinearSTERIS CorporationK171989Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal CatheterWilson-Cook Medical, Inc.K070420BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138United States Endoscopy Group, Inc.K011149DISPOSABLE BENDING CANNULA PR-233QThe Olympus Optical Co.K010993ALIEN RX MICRO CANNULA, MODEL 4530Boston Scientific Corp

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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