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FDA 510(k)

3D LINE STEROTACTIC HARDWARE ACCESSORIES

K-Number: K011255 · 2001-12-20

Applicant3D Line USA, Inc.
Decision Date2001-12-20
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

3D LINE STEROTACTIC HARDWARE ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is 3D Line USA, Inc.. It received FDA 510(k) clearance on 2001-12-20 under 510(k) number K011255. 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 3D LINE STEROTACTIC HARDWARE ACCESSORIES?

3D LINE STEROTACTIC HARDWARE ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-12-20. The listed applicant is 3D Line USA, Inc.. The 510(k) number is K011255.

When did 3D LINE STEROTACTIC HARDWARE ACCESSORIES receive FDA 510(k) clearance?

3D LINE STEROTACTIC HARDWARE ACCESSORIES received FDA 510(k) clearance on 2001-12-20, under 510(k) number K011255.

Who is the listed applicant for 3D LINE STEROTACTIC HARDWARE ACCESSORIES?

The FDA 510(k) record lists 3D Line USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D LINE STEROTACTIC HARDWARE ACCESSORIES?

The FDA product code for 3D LINE STEROTACTIC HARDWARE ACCESSORIES is HAW.

Related Clinical Trials

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Other records listing 3D Line USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K034051DYNATRAC, COD. 50-1AK031281ERGO SRSK031631STEREOTACTIC BODY FRAME, MODEL COD. 70-1AK013535EVTOOL MODEL # V. 1.0K001163DMLC IV-ERGO

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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