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FDA 510(k)

ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM

K-Number: K944612 · 1995-12-11

ApplicantCodman & Shurtleff, Inc.
Decision Date1995-12-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K944612. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM?

ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K944612.

When did ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM receive FDA 510(k) clearance?

ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM received FDA 510(k) clearance on 1995-12-11, under 510(k) number K944612.

Who is the listed applicant for ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM?

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

What is the FDA product code for ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM?

The FDA product code for ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM is LLZ.

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Official Source

View on FDA Database →

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

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