Identifiers
- 510(k) Number
- K941087 FDA 510(k)
- FDA Product Code
- LKY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5020 FDA 510(k)
- Regulation Number
- 876.5020 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pos-T-Vac AVP-1000 is an External Penile Rigidity Device, designed to assist in the treatment of erectile dysfunction by providing mechanical support to maintain penile rigidity. This device is classified as a Class II medical device under FDA regulations and is intended for use in urological applications, specifically addressing conditions requiring external penile stabilization.
The Pos-T-Vac AVP-1000 is supplied as a reusable medical device and is intended for clinical use in settings such as urology clinics or hospitals. It is not sterile at time of shipment and must be cleaned and maintained according to manufacturer instructions. The device is regulated under FDA 510(k) clearance (K941087) and falls under the classification of External Penile Rigidity Devices (regulation number 876.5020). No MRI safety information is provided in the specifications.
Frequently asked questions
What is the Pos-T-Vac AVP-1000 used for?
The Pos-T-Vac AVP-1000 is an external penile rigidity device designed to provide mechanical support for maintaining penile rigidity. It is specifically intended for use in urological applications to assist patients with erectile dysfunction by stabilizing the penis during clinical procedures or treatments.
Is the Pos-T-Vac AVP-1000 sterile when shipped?
No, the Pos-T-Vac AVP-1000 is not sterile at the time of shipment. It must be cleaned and maintained according to the manufacturer’s instructions before use to ensure proper hygiene and functionality.
How is the Pos-T-Vac AVP-1000 supplied and intended for use?
The Pos-T-Vac AVP-1000 is supplied as a reusable medical device and is intended for clinical use in settings such as urology clinics or hospitals. Its design allows for repeated use with proper cleaning and maintenance.
Can this device be used in MRI environments?
No MRI safety information is provided for the Pos-T-Vac AVP-1000, meaning its safety in MRI environments has not been established or documented by the manufacturer.
What regulatory pathway does the Pos-T-Vac AVP-1000 follow?
The Pos-T-Vac AVP-1000 is regulated under the FDA’s 510(k) clearance pathway (K941087) and is classified as a Class II medical device under FDA regulations. It was determined to be substantially equivalent to a predicate device and falls under the classification for External Penile Rigidity Devices (regulation number 876.5020).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941087 | Class II | Active |
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Manufacturer
- Manufacturer
- Pos-T-Vac Inc
- FDA Applicant
- Pos-T-Vac, Inc.
Sources (1)
- FDA 510(k) K941087 24 fields · synced Oct 1, 2026