DFINER UROLOGICAL CATHETER
FDA 510(k) clearance K013360 · decided 2002-02-20
Clearance details
- K-number
- K013360
- Device name
- DFINER UROLOGICAL CATHETER
- Applicant
- Neoseed Technology,Llc
- Decision
- Substantially Equivalent
- Date received
- 2001-10-10
- Decision date
- 2002-02-20
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- FGI
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Newburyport, 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 |
|---|---|---|
| VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000 (K023019) | Vomed Volzer Medizintechnik GmbH & Co. | 2002-12-10 |
| POLLACK CHAIN CYSOURETHROGRAM SET (K810370) | Vance Products, Inc. | 1981-03-20 |
Recalls involving this device
No recalls on record reference this clearance.