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FDA 510(k)

TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE

K-Number: K965045 · 1997-05-05

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1997-05-05
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TRISTAR LP TORCAR WITH LOW PROFILE THREADED 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 1997-05-05 under 510(k) number K965045. 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 TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE?

TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K965045.

When did TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE receive FDA 510(k) clearance?

TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE received FDA 510(k) clearance on 1997-05-05, under 510(k) number K965045.

Who is the listed applicant for TRISTAR LP TORCAR WITH LOW PROFILE THREADED 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 TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE?

The FDA product code for TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE is HET.

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

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Related Devices (Code: HET)

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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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