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FDA 510(k)

SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES

K-Number: K925266 · 1993-04-15

ApplicantLaser Surgical Systems
Decision Date1993-04-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Laser Surgical Systems. It received FDA 510(k) clearance on 1993-04-15 under 510(k) number K925266. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES?

SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES is a medical device that received FDA 510(k) clearance on 1993-04-15. The listed applicant is Laser Surgical Systems. The 510(k) number is K925266.

When did SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES receive FDA 510(k) clearance?

SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES received FDA 510(k) clearance on 1993-04-15, under 510(k) number K925266.

Who is the listed applicant for SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES?

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

What is the FDA product code for SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES?

The FDA product code for SUREPEN(TM) DISPOSABLE ACTIVE ELECTRODES is GEI.

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 Laser Surgical Systems 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.

K931445KTP/532, KTP/YAG AND KTP/YAG XPK922807FIBERLIFE

Related Devices (Code: GEI)

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

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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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