PRG Button
by Applied Medical Technologies
510(k) K946140
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946140 | Date28 Aug 1995 | 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- Withdrawn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
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The PRG Button is a tube, gastrointestinal (and accessories) device. It is classified under the medical specialties of gastroenterology and urology.
The device received FDA 510(k) clearance (K946140) on August 28, 1995, following a traditional review process. It was found substantially equivalent to a predicate device and is manufactured by Applied Medical Technologies in Independence, Ohio.
Other devices from Applied Medical Technologies
Questions
AI-generated answers, 25 Sep 2026
What is the PRG Button used for?
The PRG Button is a tube device designed for gastrointestinal applications and is also used in urology, as indicated by its classification under gastroenterology and urology medical specialties.
How was the PRG Button cleared for market?
The PRG Button received FDA 510(k) clearance through a traditional review process on August 28, 1995, after being found substantially equivalent to a predicate device under K946140.
Who manufactures the PRG Button and where is it made?
The PRG Button is manufactured by Applied Medical Technologies at their facility located at 6100 W. Creek Rd., Suite 25, Independence, Ohio 44131, United States.