VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
FDA 510(k) clearance K023019 · decided 2002-12-10
Clearance details
- K-number
- K023019
- Device name
- VOMED URETHRA OLIVE, MODELS 1420 000, 1425 000, 1430 000
- Applicant
- Vomed Volzer Medizintechnik GmbH & Co.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-11
- Decision date
- 2002-12-10
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FGI
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hot Springs, NC, 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 |
|---|---|---|
| DFINER UROLOGICAL CATHETER (K013360) | Neoseed Technology,Llc | 2002-02-20 |
| POLLACK CHAIN CYSOURETHROGRAM SET (K810370) | Vance Products, Inc. | 1981-03-20 |
Recalls involving this device
No recalls on record reference this clearance.