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FDA 510(k)

CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES

K-Number: K052680 · 2006-01-23

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2006-01-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2006-01-23 under 510(k) number K052680. 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 CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES?

CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-01-23. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K052680.

When did CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2006-01-23, under 510(k) number K052680.

Who is the listed applicant for CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES?

The FDA product code for CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES is GEX. This falls under the Gastroenterology category.

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Other records listing KARL STORZ Endoscopy-America, Inc. 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.

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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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