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FDA 510(k)

LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES

K-Number: K964076 · 1997-01-08

ApplicantLaserscope
Decision Date1997-01-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Laserscope. It received FDA 510(k) clearance on 1997-01-08 under 510(k) number K964076. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES?

LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Laserscope. The 510(k) number is K964076.

When did LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1997-01-08, under 510(k) number K964076.

Who is the listed applicant for LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES?

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 LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES?

The FDA product code for LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES is GEX. This falls under the Gastroenterology category.

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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: GEX)

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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