Porges Sphincterotomes
by Porges Corp.
510(k) K896426
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896426 | Date22 Jan 1990 | 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- Withdrawn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
- KNS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4300
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Porges Sphincterotomes are electrosurgical endoscopic devices used for sphincterotomy procedures. They are classified as Class II devices under special controls and are intended for use in medical settings.
The device is supplied as a single-use unit and is not reusable. It is not specified whether the device is sterile or non-sterile. The device is not MRI safe. The device is regulated under FDA 510(k) clearance with decision code SESE. The device is intended for use in gastroenterology and urology procedures.