SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
FDA 510(k) clearance K905574 · decided 1991-01-24
Clearance details
- K-number
- K905574
- Device name
- SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
- Applicant
- E-Z-Em, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-12
- Decision date
- 1991-01-24
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- FGD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Worcester, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NAJA Gastrointestinal Catheter (K223890) | Chess Medical, Inc. | 2023-06-16 |
| DUAL FLEX NON-LATEX (K905026) | Mmi, Inc. | 1991-12-18 |
| SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF (K904299) | E-Z-Em, Inc. | 1990-11-27 |
| MAGLINTE ENTEROCLYSIS CATHETER (K884379) | Lafayette Pharmacal, Inc. | 1989-02-28 |
| DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF (K872006) | Mac Lee Medical Products | 1987-11-17 |
Recalls involving this device
No recalls on record reference this clearance.