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FDA 510(k)

RETRACTOR LITE

K-Number: K083710 · 2009-02-23

ApplicantThomas Surgical Instruments, Inc.
Decision Date2009-02-23
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RETRACTOR LITE is the device name listed in this FDA 510(k) record. The listed applicant is Thomas Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2009-02-23 under 510(k) number K083710. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETRACTOR LITE?

RETRACTOR LITE is a medical device that received FDA 510(k) clearance on 2009-02-23. The listed applicant is Thomas Surgical Instruments, Inc.. The 510(k) number is K083710.

When did RETRACTOR LITE receive FDA 510(k) clearance?

RETRACTOR LITE received FDA 510(k) clearance on 2009-02-23, under 510(k) number K083710.

Who is the listed applicant for RETRACTOR LITE?

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

What is the FDA product code for RETRACTOR LITE?

The FDA product code for RETRACTOR LITE is FST.

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Related Devices (Code: FST)

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.

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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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