Convenience Tray
by Johannah Medical Services, Inc.
510(k) K770370
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770370 | Date16 Mar 1977 | 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- Withdrawn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
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Convenience Tray is a medical device classified under gastroenterology and urology. It is designed to facilitate clinical procedures within a general hospital setting.
This device is regulated under FDA 510(k) clearance number K770370. It is manufactured by Johannah Medical Services, Inc. and is categorized as a class 2 medical device.
Other devices from Johannah Medical Services, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the intended use of the Convenience Tray?
The Convenience Tray is designed to facilitate clinical procedures within a general hospital setting, specifically supporting gastroenterology and urology applications.
What is the regulatory status of this device?
The Convenience Tray is a class 2 medical device that has received FDA 510(k) clearance under the number K770370, indicating it has been found substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the Convenience Tray?
The device is manufactured by Johannah Medical Services, Inc., located in McHenry, Illinois.