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FDA 510(k)

ASI UROPLASTY LASER CYSTOSCOPE

K-Number: K921990 · 1992-10-28

ApplicantAdvanced Surgical Intervention, Inc.
Decision Date1992-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASI UROPLASTY 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 1992-10-28 under 510(k) number K921990. 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 UROPLASTY LASER CYSTOSCOPE?

ASI UROPLASTY LASER CYSTOSCOPE is a medical device that received FDA 510(k) clearance on 1992-10-28. The listed applicant is Advanced Surgical Intervention, Inc.. The 510(k) number is K921990.

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

ASI UROPLASTY LASER CYSTOSCOPE received FDA 510(k) clearance on 1992-10-28, under 510(k) number K921990.

Who is the listed applicant for ASI UROPLASTY 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 UROPLASTY LASER CYSTOSCOPE?

The FDA product code for ASI UROPLASTY 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.

K954215MINIGUARDK926110ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENTK930361ASI CYSTOLASE LASER CYSTOSCOPEK902585UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETERK901336ASI HEMOSTASIS CATHETERK896713ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.

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Related Devices (Code: GEX)

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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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