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FDA 510(k)

WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM

K-Number: K964436 · 1997-01-30

ApplicantWestern Surgical Instrument Co.
Decision Date1997-01-30
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Western Surgical Instrument Co.. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K964436. 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 WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM?

WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Western Surgical Instrument Co.. The 510(k) number is K964436.

When did WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM receive FDA 510(k) clearance?

WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM received FDA 510(k) clearance on 1997-01-30, under 510(k) number K964436.

Who is the listed applicant for WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM?

The FDA 510(k) record lists Western Surgical Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM?

The FDA product code for WESTERN SURGICAL REUSABLE LAPAROSCOPIC TROCAR SYSTEM is 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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