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FDA 510(k)

SHIELDED SURGICAL TROCAR

K-Number: K971475 · 1997-08-21

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1997-08-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHIELDED SURGICAL TROCAR 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 1997-08-21 under 510(k) number K971475. 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 SHIELDED SURGICAL TROCAR?

SHIELDED SURGICAL TROCAR is a medical device that received FDA 510(k) clearance on 1997-08-21. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K971475.

When did SHIELDED SURGICAL TROCAR receive FDA 510(k) clearance?

SHIELDED SURGICAL TROCAR received FDA 510(k) clearance on 1997-08-21, under 510(k) number K971475.

Who is the listed applicant for SHIELDED SURGICAL TROCAR?

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 SHIELDED SURGICAL TROCAR?

The FDA product code for SHIELDED SURGICAL TROCAR 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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