Endoscopic Manual Air Insufflator
by Jayco Pharmaceuticals 510(k)
Active
510(k) K844689
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844689 | Date2 Jan 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FCX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Endoscopic Manual Air Insufflator is a medical device classified as an insufflator for use during endoscopic procedures. It is designed to provide air insufflation to assist in the visualization and examination of internal body cavities.
This device is identified by FDA 510(k) number K844689 and is regulated under 21 CFR 876.1500. It is intended for use within the fields of gastroenterology and urology.
Other devices from Jayco Pharmaceuticals
Questions
AI-generated answers, 21 Sep 2026
What is the primary purpose of the Endoscopic Manual Air Insufflator?
This device is designed to provide air insufflation during endoscopic procedures. Its primary function is to assist clinicians in the visualization and examination of internal body cavities.
Which medical specialties is this insufflator intended for?
The device is intended for use within the fields of gastroenterology and urology to support endoscopic examinations.
What is the regulatory status of this device?
The Endoscopic Manual Air Insufflator is identified by FDA 510(k) number K844689 and is regulated under 21 CFR 876.1500, having been cleared through the traditional 510(k) process.