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FDA 510(k)

SKYLARK URO PROBE

K-Number: K053007 · 2005-12-05

ApplicantSkylark Device & Systems Co., Ltd.
Decision Date2005-12-05
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKYLARK URO PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device & Systems Co., Ltd.. It received FDA 510(k) clearance on 2005-12-05 under 510(k) number K053007. 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 SKYLARK URO PROBE?

SKYLARK URO PROBE is a medical device that received FDA 510(k) clearance on 2005-12-05. The listed applicant is Skylark Device & Systems Co., Ltd.. The 510(k) number is K053007.

When did SKYLARK URO PROBE receive FDA 510(k) clearance?

SKYLARK URO PROBE received FDA 510(k) clearance on 2005-12-05, under 510(k) number K053007.

Who is the listed applicant for SKYLARK URO PROBE?

The FDA 510(k) record lists Skylark Device & Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKYLARK URO PROBE?

The FDA product code for SKYLARK URO PROBE is KPI.

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Other records listing Skylark Device & Systems Co., Ltd. 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.

K050174BIO-STIM KITK043306SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IRK034005SDS-4IK002832CONDUCTIVE GEL FOR ULTRASOUNDK992652SD-730 IF-SDS, PERFECT PULSE IF-SDS

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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