Xtend
by Walling Medical Equipment Co.
510(k) K980752
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980752 | Date6 May 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 28 Sep 2026
The Xtend is a device classified as an External Penile Rigidity device, with a product code of LKY. It falls under the medical specialty descriptions of Gastroenterology and Urology. The device has a regulation number of 876.5020 and is classified as a class 2 device.
The Xtend is supplied by Walling Medical Equipment Co. and has been authorized with an FDA 510K clearance, with the decision description being Substantially Equivalent. The device has a unique k number, K980752, and is associated with multiple registration numbers and fei numbers. It is intended for over-the-counter use.
Other devices from Walling Medical Equipment Co.
Questions
AI-generated answers, 28 Sep 2026
What is the Xtend device used for?
The Xtend is used as an External Penile Rigidity device, intended for over-the-counter use, and falls under the medical specialties of Gastroenterology and Urology.
Is the Xtend device sterile?
The provided data does not specify the sterility of the Xtend device, but it has been authorized with an FDA 510K clearance, indicating it meets certain regulatory standards.
What is the regulatory classification of the Xtend device?
The Xtend is classified as a class 2 device with a regulation number of 876.5020 and has been cleared through the FDA 510K process, determined to be Substantially Equivalent.