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FDA 510(k)

NON-SHIELDED SURGICAL TROCAR AND SLEEVE

K-Number: K963760 · 1997-01-08

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1997-01-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NON-SHIELDED SURGICAL TROCAR 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 1997-01-08 under 510(k) number K963760. 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 NON-SHIELDED SURGICAL TROCAR AND SLEEVE?

NON-SHIELDED SURGICAL TROCAR AND SLEEVE is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K963760.

When did NON-SHIELDED SURGICAL TROCAR AND SLEEVE receive FDA 510(k) clearance?

NON-SHIELDED SURGICAL TROCAR AND SLEEVE received FDA 510(k) clearance on 1997-01-08, under 510(k) number K963760.

Who is the listed applicant for NON-SHIELDED SURGICAL TROCAR 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 NON-SHIELDED SURGICAL TROCAR AND SLEEVE?

The FDA product code for NON-SHIELDED SURGICAL TROCAR AND SLEEVE is GCJ.

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Other records listing Ethicon Endo-Surgery, 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.

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Related Devices (Code: GCJ)

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.

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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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