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FDA 510(k)

BOSS-2000-2 VACUUM ERECTION DEVICE

K-Number: K012672 · 2001-11-09

ApplicantPos-T-Vac, Inc.
Decision Date2001-11-09
Product CodeLKY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BOSS-2000-2 VACUUM ERECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pos-T-Vac, Inc.. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K012672. 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 BOSS-2000-2 VACUUM ERECTION DEVICE?

BOSS-2000-2 VACUUM ERECTION DEVICE is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Pos-T-Vac, Inc.. The 510(k) number is K012672.

When did BOSS-2000-2 VACUUM ERECTION DEVICE receive FDA 510(k) clearance?

BOSS-2000-2 VACUUM ERECTION DEVICE received FDA 510(k) clearance on 2001-11-09, under 510(k) number K012672.

Who is the listed applicant for BOSS-2000-2 VACUUM ERECTION DEVICE?

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

What is the FDA product code for BOSS-2000-2 VACUUM ERECTION DEVICE?

The FDA product code for BOSS-2000-2 VACUUM ERECTION DEVICE is LKY.

Related Clinical Trials

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Other records listing Pos-T-Vac, 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.

K020154VT-1K020258SUPPORT SLEEVEK012670BOSS 2000-3 VACUUM ERECTION DEVICEK983246POS-T-VAC (IVP-600)K983245POS-T-VAC (AVP-1000)K981180REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KIT

View all 12 devices →

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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