510(k) K223890
- Device
- NAJA Gastrointestinal Catheter
- Applicant
- Chess Medical, Inc.
- 510(k) number
- K223890
- Product code
- FGD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-16
- Date received
- 2022-12-27
- Regulation
- 876.5980
- Classification name
- Catheter, Retention, Barium Enema With Bag
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dr. Yen-I Chen
- Address
- 1650 Sherbrooke St. W., Suite 9e Montreal CA H3H 1C9 H3H 1C9
FDA Registration Numbers#
- 1417592
- 3010339057
- 3006210673
- 3038190598
- 3010291427
- 3008496560
- 3010547268
- 3005099803
- 3025337868
- 2411512
- 9610849
- 3006536657
- 3016872092
- 3011752740
Source Documents#
Other 510(k) Records For Product Code FGD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K905026 | DUAL FLEX NON-LATEX | Mmi, Inc. | 1991-12-18 |
| K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | E-Z-Em, Inc. | 1991-01-24 |
| K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | E-Z-Em, Inc. | 1990-11-27 |
| K884379 | MAGLINTE ENTEROCLYSIS CATHETER | Lafayette Pharmacal, Inc. | 1989-02-28 |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Mac Lee Medical Products | 1987-11-17 |