510(k) K053547
- Device
- SMARTPILL GI MONITORING SYSTEM
- Applicant
- THE SMARTPILL CORPORATION
- 510(k) number
- K053547
- Product code
- NYV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-07-18
- Date received
- 2005-12-20
- Regulation
- 876.1725
- Classification name
- Gastrointestinal Motility System, Capsule
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHLEEN SELOVER
- Address
- 847 Main St. Buffalo NY US 14203 14203
FDA Registration Numbers#
- 3016544248
- 9710107
- 3018094310
- 3027568582
- 3017496797
Source Documents#
Other 510(k) Records For Product Code NYV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253569 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2026-05-22 |
| K250940 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2025-06-26 |
| K250493 | MotiliCap GI Monitoring System | Anx Robotica Corporation | 2025-05-21 |
| K092342 | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | The Smartpill Corporation | 2009-10-30 |
Legacy Summary#
summary
FDA Review#
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