Ascorbic Acid
by Organon Teknika Corp. 510(k)
Active
510(k) K842215
Overview
Ascorbic Acid is a medical device classified as a Subsystem for Water Purification. It is used in water purification systems to maintain water quality and safety.
The device is supplied by Organon Teknika Corp. and has received FDA 510(k) clearance with the K number K842215. It is regulated under product code FIP and is intended for use in gastroenterology and urology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK842215 | Date2 Aug 1984 | 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- Withdrawn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
- FIP
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5665
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Organon Teknika Corp.
Questions
What is the Ascorbic Acid medical device used for?
Ascorbic Acid is a medical device classified as a Subsystem for Water Purification. It is used in water purification systems to maintain water quality and safety, specifically intended for gastroenterology and urology applications.
How is the Ascorbic Acid device supplied?
The Ascorbic Acid device is supplied by Organon Teknika Corp. It is a component designed for integration into water purification systems to help maintain water quality in medical settings.
What is the regulatory status of the Ascorbic Acid device?
The Ascorbic Acid device has received FDA 510(k) clearance with K number K842215. It is regulated under product code FIP and was determined to be substantially equivalent to predicate devices.
Is the Ascorbic Acid device single-use or reusable?
The device data does not specify whether the Ascorbic Acid device is single-use or reusable. As a subsystem for water purification, it may be designed for either use pattern depending on the specific implementation in the water purification system.