Pharmaseal Endoscopy Prep Kit Upper and Lower
by American Pharmaseal Div. Ahsc
510(k) K874045
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874045 | Date3 Dec 1987 | 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- Withdrawn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
- NWU
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Pharmaseal Endoscopy Prep Kit Upper and Lower is an Endoscope Introducer Kit designed to facilitate preparation of both upper and lower endoscopic examinations. It provides the necessary components to introduce and secure the endoscope during gastrointestinal and urological procedures. The kit is intended for use by qualified healthcare professionals performing endoscopy.
The kit is cleared under FDA 510(k) submission K874045 as a Class II medical device and carries the product code NWU. It is supplied as a complete preparation set and is identified as a single-use device, though the specific sterility status is not detailed in the available data. The device is marketed in the United States by American Pharmaseal Div. Ahsc and is regulated according to the applicable FDA requirements.