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FDA 510(k)

DETRUSAN 500

K-Number: K994109 · 2000-08-03

ApplicantInnovamed USA, Inc.
Decision Date2000-08-03
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DETRUSAN 500 is the device name listed in this FDA 510(k) record. The listed applicant is Innovamed USA, Inc.. It received FDA 510(k) clearance on 2000-08-03 under 510(k) number K994109. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETRUSAN 500?

DETRUSAN 500 is a medical device that received FDA 510(k) clearance on 2000-08-03. The listed applicant is Innovamed USA, Inc.. The 510(k) number is K994109.

When did DETRUSAN 500 receive FDA 510(k) clearance?

DETRUSAN 500 received FDA 510(k) clearance on 2000-08-03, under 510(k) number K994109.

Who is the listed applicant for DETRUSAN 500?

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

What is the FDA product code for DETRUSAN 500?

The FDA product code for DETRUSAN 500 is KPI.

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Related Devices (Code: KPI)

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.

K262353BTL-299-FBTL Industries, Inc.K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)Pontemedag

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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