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FDA 510(k)

PLANISIGHT LINASYS

K-Number: K082228 · 2008-09-22

ApplicantPathfinder Therapeutics, Inc.
Decision Date2008-09-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PLANISIGHT LINASYS is the device name listed in this FDA 510(k) record. The listed applicant is Pathfinder Therapeutics, Inc.. It received FDA 510(k) clearance on 2008-09-22 under 510(k) number K082228. 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 PLANISIGHT LINASYS?

PLANISIGHT LINASYS is a medical device that received FDA 510(k) clearance on 2008-09-22. The listed applicant is Pathfinder Therapeutics, Inc.. The 510(k) number is K082228.

When did PLANISIGHT LINASYS receive FDA 510(k) clearance?

PLANISIGHT LINASYS received FDA 510(k) clearance on 2008-09-22, under 510(k) number K082228.

Who is the listed applicant for PLANISIGHT LINASYS?

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

What is the FDA product code for PLANISIGHT LINASYS?

The FDA product code for PLANISIGHT LINASYS is LLZ.

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Other records listing Pathfinder Therapeutics, 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.

K101979EXPLORER LIVER (PASSIVE TRACKING)K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEMK071063LINASYS

Related Devices (Code: 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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