Product code FGD
- Device name
- Catheter, Retention, Barium Enema With Bag
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical, Inc. | 2023-06-16 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10815112021525 | Enema Ring: Fluid Collection Device | Bracco Diagnostics Inc. | 2025-05-16 |
| 10815112021228 | Retention Cuff Inflator | Bracco Diagnostics Inc. | 2023-05-25 |
| 10815112021211 | Blue Air Bulb Insufflator | Bracco Diagnostics Inc. | 2023-05-25 |
| 10815112021198 | Miller Enema Air Tip with Retention Cuff | Bracco Diagnostics Inc. | 2023-05-25 |
| 10815112021181 | Miller Enema Air Tip with Non-Latex Retention Cuff | Bracco Diagnostics Inc. | 2023-05-25 |
| 10815112021167 | Rounded Flexi Tip Adult Enema Tip | Bracco Diagnostics Inc. | 2023-05-25 |
| 10080196035748 | MEDLINE INDUSTRIES, INC. | MEDLINE INDUSTRIES, INC. | 2021-01-05 |
| 10080196035731 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-05 |
| 10815112020641 | FLEXI-STOME Cone Colostomy Tip | Bracco Diagnostics Inc. | 2020-06-29 |
| 10815112021020 | Miller Enema Air Tip: Without Retention Cuff | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020207 | CT Enema Administration Kit: Enema Delivery System | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020818 | Enema Kit: Empty Enema Bag Delivery System | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020825 | Enema Kit: Empty Enema Bag Delivery System | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020856 | """Y"" Connector with Tubing" | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021075 | Junior Flexi Tip Pediatric Enema Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021068 | 18 French Pediatric Flexi Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021051 | FLEXI-STOME Nipple Colostomy Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021044 | FLEXI-STOME Cone Colostomy Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021037 | 14 French Pediatric Flexi Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020887 | Retention Cuff Inflator | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021013 | 24 Fr Infant Flexi Tip: Pediatric Enema Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112021006 | XL Flexi Tip: Adult Enema Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020993 | Rounded Flexi Tip Adult Enema Tip | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020986 | Super XL Enema System | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020979 | Miller Enema Air Tip with Retention Cuff | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020962 | Miller Enema Air Tip with Non-Latex Retention Cuff | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020955 | Enema Ring: Fluid Collection Device | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020917 | Safti Cuff | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020900 | SaftiCuff DK | Bracco Diagnostics Inc. | 2016-09-19 |
| 10815112020894 | Flexi Air Tip XL | Bracco Diagnostics Inc. | 2016-09-19 |