Interstim 100 System
by Buckman Co., Inc. 510(k)
Active
510(k) K861136
Overview
The Interstim 100 System is a device used for sacral neuromodulation. It is substantially equivalent for some indications and is classified under the product code IPF. The device is used for physical medicine applications.
The Interstim 100 System is supplied by Buckman Co., Inc. and has received FDA 510K clearance. The device has a specific size, but the exact dimensions are not provided in the available data. It is intended for use in a clinical setting and is subject to regulatory authorizations, including FDA clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK861136 | Date9 Jul 1986 | 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- Withdrawn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
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SN