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FDA 510(k)

ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR

K-Number: K904104 · 1990-12-05

ApplicantETHICON, Inc.
Decision Date1990-12-05
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1990-12-05 under 510(k) number K904104. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR?

ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR is a medical device that received FDA 510(k) clearance on 1990-12-05. The listed applicant is ETHICON, Inc.. The 510(k) number is K904104.

When did ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR receive FDA 510(k) clearance?

ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR received FDA 510(k) clearance on 1990-12-05, under 510(k) number K904104.

Who is the listed applicant for ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR?

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

What is the FDA product code for ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR?

The FDA product code for ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR is HET.

Related Clinical Trials

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.

Other records listing ETHICON, 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: HET)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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