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FDA 510(k)

RADLITE TISSUE RETRACTOR SYSTEM

K-Number: K022989 · 2002-11-25

ApplicantGenzyme Biosurgery
Decision Date2002-11-25
Product CodeFSW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADLITE TISSUE RETRACTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Biosurgery. It received FDA 510(k) clearance on 2002-11-25 under 510(k) number K022989. The device is classified under product code FSW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADLITE TISSUE RETRACTOR SYSTEM?

RADLITE TISSUE RETRACTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2002-11-25. The listed applicant is Genzyme Biosurgery. The 510(k) number is K022989.

When did RADLITE TISSUE RETRACTOR SYSTEM receive FDA 510(k) clearance?

RADLITE TISSUE RETRACTOR SYSTEM received FDA 510(k) clearance on 2002-11-25, under 510(k) number K022989.

Who is the listed applicant for RADLITE TISSUE RETRACTOR SYSTEM?

The FDA 510(k) record lists Genzyme Biosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADLITE TISSUE RETRACTOR SYSTEM?

The FDA product code for RADLITE TISSUE RETRACTOR SYSTEM is FSW.

Related Clinical Trials

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Other records listing Genzyme Biosurgery 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.

K031554S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEMK030212MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTUREK022410SAPH-LOOP LIGATING LOOP

Related Devices (Code: FSW)

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.

K013511XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~)Aculux, Inc.K943342MEDICAM XENON LIGHT SOURCEM.P. Video, Inc.K934337CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCECuda Products Co.K922279ILLUMINATOR IV MINOR SURGERY LIGHTMedical Illumination, Inc.K913135LM-300TWINLeisegang Medical, Inc.K894319MEDICAL DYNAMICS LIGHT SOURCEMedical Dynamics, Inc.

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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