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FDA 510(k)

SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE

K-Number: K873892 · 1988-02-02

ApplicantLaserguide
Decision Date1988-02-02
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE is the device name listed in this FDA 510(k) record. The listed applicant is Laserguide. It received FDA 510(k) clearance on 1988-02-02 under 510(k) number K873892. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE?

SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE is a medical device that received FDA 510(k) clearance on 1988-02-02. The listed applicant is Laserguide. The 510(k) number is K873892.

When did SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE receive FDA 510(k) clearance?

SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE received FDA 510(k) clearance on 1988-02-02, under 510(k) number K873892.

Who is the listed applicant for SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE?

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

What is the FDA product code for SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE?

The FDA product code for SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE is LNK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Laserguide 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.

K880071SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USEK875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USEK873571LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBEK873664LIGHT-SPOT FIBEROPTIC LASER HANDPIECE

Related Devices (Code: LNK)

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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.

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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