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FDA 510(k)

SE-200

K-Number: K012620 · 2001-11-09

ApplicantVts, Inc.
Decision Date2001-11-09
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SE-200 is the device name listed in this FDA 510(k) record. The listed applicant is Vts, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012620. The device is classified under product code LKY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SE-200?

SE-200 is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Vts, Inc.. The 510(k) number is K012620.

When did SE-200 receive FDA 510(k) clearance?

SE-200 received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012620.

Who is the listed applicant for SE-200?

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

What is the FDA product code for SE-200?

The FDA product code for SE-200 is LKY.

Other records listing Vts, 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.

K012619VT-1K012639SE-300 VACUUM THERAPY SYSTEMK012662SE-100 VACUUM ERECTION DEVICEK992442V.T.S., INC. (V.T.-3)

Related Devices (Code: LKY)

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.

K041573NANMA VACUUM PUMP PROXZEK MODEL 2M9498SNanma Mfg Co., Ltd.K032776VACURECT VACUUM CONSTRICTION DEVICEVacurect Manufacturing (Pty) , Ltd.K030119NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.K030913NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013113MODIFICATION TO NANMA VACUUM PUMPNanma Mfg Co., Ltd.K013051NANMA ADJUSTABLE CONSTRICTION RINGNanma Mfg Co., Ltd.

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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