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FDA 510(k)

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.

K-Number: K896713 · 1990-05-24

ApplicantAdvanced Surgical Intervention, Inc.
Decision Date1990-05-24
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. 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 1990-05-24 under 510(k) number K896713. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.?

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. is a medical device that received FDA 510(k) clearance on 1990-05-24. The listed applicant is Advanced Surgical Intervention, Inc.. The 510(k) number is K896713.

When did ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. receive FDA 510(k) clearance?

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. received FDA 510(k) clearance on 1990-05-24, under 510(k) number K896713.

Who is the listed applicant for ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.?

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 TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.?

The FDA product code for ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. is KOE.

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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 CYSTOSCOPEK921990ASI UROPLASTY LASER CYSTOSCOPEK902585UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETERK901336ASI HEMOSTASIS CATHETER

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Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical Corp.

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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