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FDA 510(k)

ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE

K-Number: K972578 · 1997-10-01

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1997-10-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K972578. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE?

ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K972578.

When did ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE receive FDA 510(k) clearance?

ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972578.

Who is the listed applicant for ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE?

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

What is the FDA product code for ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE?

The FDA product code for ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE is GCJ.

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Other records listing Ethicon Endo-Surgery, Inc. as applicant

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Related Devices (Code: GCJ)

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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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