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FDA 510(k)

ASI CYSTOLASE LASER CYSTOSCOPE

K-Number: K930361 · 1993-04-29

ApplicantAdvanced Surgical Intervention, Inc.
Decision Date1993-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASI CYSTOLASE LASER CYSTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Surgical Intervention, Inc.. It received FDA 510(k) clearance on 1993-04-29 under 510(k) number K930361. 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 ASI CYSTOLASE LASER CYSTOSCOPE?

ASI CYSTOLASE LASER CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 1993-04-29. The listed applicant is Advanced Surgical Intervention, Inc.. The 510(k) number is K930361.

When did ASI CYSTOLASE LASER CYSTOSCOPE receive FDA 510(k) clearance?

ASI CYSTOLASE LASER CYSTOSCOPE received FDA 510(k) clearance on 1993-04-29, under 510(k) number K930361.

Who is the listed applicant for ASI CYSTOLASE LASER CYSTOSCOPE?

The FDA 510(k) record lists Advanced Surgical Intervention, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASI CYSTOLASE LASER CYSTOSCOPE?

The FDA product code for ASI CYSTOLASE LASER CYSTOSCOPE is GEX. This falls under the Gastroenterology category.

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Other records listing Advanced Surgical Intervention, 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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