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FDA 510(k)

AMS OPTILUME(TM) PROSTATE BALLOON DILATOR

K-Number: K900761 · 1990-05-17

ApplicantAmerican Medical Systems, Inc.
Decision Date1990-05-17
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMS OPTILUME(TM) PROSTATE BALLOON DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-05-17 under 510(k) number K900761. 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 AMS OPTILUME(TM) PROSTATE BALLOON DILATOR?

AMS OPTILUME(TM) PROSTATE BALLOON DILATOR is a medical device that received FDA 510(k) clearance on 1990-05-17. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K900761.

When did AMS OPTILUME(TM) PROSTATE BALLOON DILATOR receive FDA 510(k) clearance?

AMS OPTILUME(TM) PROSTATE BALLOON DILATOR received FDA 510(k) clearance on 1990-05-17, under 510(k) number K900761.

Who is the listed applicant for AMS OPTILUME(TM) PROSTATE BALLOON DILATOR?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMS OPTILUME(TM) PROSTATE BALLOON DILATOR?

The FDA product code for AMS OPTILUME(TM) PROSTATE BALLOON DILATOR is KOE.

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Other records listing American Medical Systems, 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.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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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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