Endo I/A Probe
510(k) K924149
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924149 | Date26 Jan 1993 | 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- Withdrawn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
- GCJ
- 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
An endo I/A probe is a device used for irrigation and aspiration during endoscopic procedures. It is designed to deliver fluid and remove debris or fluids from body cavities.
This device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization. It is used in gastroenterology and urology settings, with authorization via FDA 510(k) clearance under product code GCJ.
Other devices from Snowden-Pencer
Questions
AI-generated answers, 21 Sep 2026
What is the ENDO I/A PROBE used for?
The ENDO I/A PROBE is used for irrigation and aspiration during endoscopic procedures to deliver fluid and remove debris or fluids from body cavities, specifically in gastroenterology and urology settings.
How is the ENDO I/A PROBE supplied and is it reusable?
The ENDO I/A PROBE is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization, as stated in the device description.
What regulatory pathway was used for the ENDO I/A PROBE?
The ENDO I/A PROBE received authorization via FDA 510(k) clearance, as indicated in the AUTHORIZATIONS field and confirmed by the decision_type and k_number.