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FDA 510(k)

SH-1 SURGICAL HOLDER FOR TELESCOPE

K-Number: K960068 · 1997-05-05

ApplicantOlympus America, Inc.
Decision Date1997-05-05
Product CodeOCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SH-1 SURGICAL HOLDER FOR TELESCOPE 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 1997-05-05 under 510(k) number K960068. The device is classified under product code OCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SH-1 SURGICAL HOLDER FOR TELESCOPE?

SH-1 SURGICAL HOLDER FOR TELESCOPE is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Olympus America, Inc.. The 510(k) number is K960068.

When did SH-1 SURGICAL HOLDER FOR TELESCOPE receive FDA 510(k) clearance?

SH-1 SURGICAL HOLDER FOR TELESCOPE received FDA 510(k) clearance on 1997-05-05, under 510(k) number K960068.

Who is the listed applicant for SH-1 SURGICAL HOLDER FOR TELESCOPE?

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 SH-1 SURGICAL HOLDER FOR TELESCOPE?

The FDA product code for SH-1 SURGICAL HOLDER FOR TELESCOPE is OCV.

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Other records listing Olympus America, 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.

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

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Related Devices (Code: OCV)

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.

K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc.K232405ENDOFIX EXOAktormed GmbHK190576WalterLorenz Surgical Assist Arm Scope HolderBiomet MicrofixationK102179ENVIEW (TM)Carefusion 2200K093616V. MUELLER CAMERA CONTROLLER WITH STORAGE CARTCarefusion 2200K992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33Integra Neurocare, LLC

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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