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Asi Uroplasty Laser Cystoscope

by Advanced Surgical Intervention, Inc.

510(k) K921990

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921990 Date28 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ASI UROPLASTY LASER CYSTOSCOPE is a cystoscope device intended for use in general and plastic surgery procedures. It is a laser-equipped endoscopic instrument designed for visual examination and intervention within the urinary tract.

This device received FDA 510(k) clearance under K number K921990 and is classified under product code GEX. It is manufactured by Advanced Surgical Intervention, Inc. and was cleared via the traditional 510(k) pathway following review by the General and Plastic Surgery advisory committee.

Other devices from Advanced Surgical Intervention, Inc.

See all devices from Advanced Surgical Intervention, Inc. →

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ASI UROPLASTY LASER CYSTOSCOPE used for?

    The ASI UROPLASTY LASER CYSTOSCOPE is intended for visual examination and intervention within the urinary tract during general and plastic surgery procedures, combining endoscopic viewing with laser capability for diagnostic and therapeutic use.

  • How was the ASI UROPLASTY LASER CYSTOSCOPE cleared for market?

    The device received FDA 510(k) clearance under K number K921990 through the traditional pathway, following review by the General and Plastic Surgery advisory committee, and was determined to be substantially equivalent to a legally marketed predicate device.

  • Who manufactures the ASI UROPLASTY LASER CYSTOSCOPE and where is it located?

    The ASI UROPLASTY LASER CYSTOSCOPE is manufactured by Advanced Surgical Intervention, Inc., located at 951 Calle Amanecer, San Clemente, CA 92672, United States.