ERCO-VAC
by Ercons, Inc. 510(k)
Active
510(k) K981357
Overview
The ERCO-VAC is a Device, External Penile Rigidity (Regulation Number 876.5020), designed to provide external support for penile rigidity. It is classified under the product code LKY and falls within the Gastroenterology and Urology specialty categories. This device is intended for use in maintaining or assisting penile erection through mechanical means, aiding in conditions requiring external rigidity support.
The ERCO-VAC is supplied as a reusable device and is cleared for use in clinical settings by the FDA under the Traditional 510(k) pathway. It is not described as sterile or single-use in the regulatory data. The device is manufactured by Ercons, Inc., and its regulatory submission (K981357) was determined to be Substantially Equivalent to a predicate device. No specific MRI safety classification or storage instructions are provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK981357 | Date24 Nov 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LKY
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5020
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Ercons, Inc.
Questions
What is the primary purpose of the ERCO-VAC device, and how does it function?
The ERCO-VAC is designed to provide external support for penile rigidity, helping to maintain or assist penile erection through mechanical means. It is not intended for internal use or medical procedures but rather as an external aid for conditions requiring external rigidity support, such as certain clinical or diagnostic scenarios.
Is the ERCO-VAC a single-use or reusable device, and what does this mean for its maintenance?
The ERCO-VAC is reusable, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. Since it is not described as sterile in the regulatory data, users must follow manufacturer guidelines for disinfection and care to ensure safe, repeated use.
What regulatory pathway was used for FDA clearance of the ERCO-VAC, and what does this imply about its safety and equivalence?
The ERCO-VAC was cleared via the Traditional 510(k) pathway, meaning it was determined to be Substantially Equivalent (SESE) to a predicate device already on the market. This implies that its design and performance meet FDA standards for safety and effectiveness, based on comparisons to an existing, approved device.
Are there multiple sizes or models of the ERCO-VAC, and how can I identify the correct one for a patient?
The ERCO-VAC is listed with multiple registration numbers (e.g., 3016028125, 3015200846, etc.), which may correspond to different models or variations. While exact sizing details are not provided in the regulatory data, these identifiers suggest variations may exist. Clinicians should consult the manufacturer’s documentation or contact Ercons, Inc. for guidance on selecting the appropriate model for a patient’s needs.
Does the ERCO-VAC have any special storage requirements, or can it be kept under standard conditions?
The regulatory data does not specify MRI safety classification or storage instructions for the ERCO-VAC. Until manufacturer guidelines are consulted, it is safest to assume standard room-temperature storage away from direct sunlight or extreme temperatures, following general medical device care practices.