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FDA 510(k)

NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)

K-Number: K925130 · 1993-03-18

ApplicantLaserscope
Decision Date1993-03-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K925130. 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 NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)?

NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Laserscope. The 510(k) number is K925130.

When did NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) receive FDA 510(k) clearance?

NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) received FDA 510(k) clearance on 1993-03-18, under 510(k) number K925130.

Who is the listed applicant for NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)?

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

What is the FDA product code for NESSY SURESTICK(TM)/STANDARD SURESTICK(TM)?

The FDA product code for NESSY SURESTICK(TM)/STANDARD SURESTICK(TM) is GEI.

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Other records listing Laserscope 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.

K062719GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESK061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESK034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIESK024206AURA ISURGICAL LASER SYSTEM & ACCESSORIESK020021LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)K010834LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES

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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

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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