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FDA 510(k)

INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM

K-Number: K936011 · 1994-09-21

ApplicantInvamed, Inc.
Decision Date1994-09-21
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Invamed, Inc.. It received FDA 510(k) clearance on 1994-09-21 under 510(k) number K936011. 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 INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM?

INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-21. The listed applicant is Invamed, Inc.. The 510(k) number is K936011.

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

INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM received FDA 510(k) clearance on 1994-09-21, under 510(k) number K936011.

Who is the listed applicant for INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM?

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

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

The FDA product code for INVAMED 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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