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FDA 510(k)

INSIGHT IMAGE GUIDED SURGICAL SYSTEM

K-Number: K001642 · 2000-09-12

ApplicantSurgical Insights, Inc.
Decision Date2000-09-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INSIGHT IMAGE GUIDED SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Insights, Inc.. It received FDA 510(k) clearance on 2000-09-12 under 510(k) number K001642. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSIGHT IMAGE GUIDED SURGICAL SYSTEM?

INSIGHT IMAGE GUIDED SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-12. The listed applicant is Surgical Insights, Inc.. The 510(k) number is K001642.

When did INSIGHT IMAGE GUIDED SURGICAL SYSTEM receive FDA 510(k) clearance?

INSIGHT IMAGE GUIDED SURGICAL SYSTEM received FDA 510(k) clearance on 2000-09-12, under 510(k) number K001642.

Who is the listed applicant for INSIGHT IMAGE GUIDED SURGICAL SYSTEM?

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

What is the FDA product code for INSIGHT IMAGE GUIDED SURGICAL SYSTEM?

The FDA product code for INSIGHT IMAGE GUIDED SURGICAL SYSTEM is HAW.

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Related Devices (Code: HAW)

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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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