ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
FDA 510(k) clearance K021142 · decided 2002-10-01
Clearance details
- K-number
- K021142
- Device name
- ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
- Applicant
- Fortune Medical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-09
- Decision date
- 2002-10-01
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Taipei Hsien, TW
- 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.
Recalls involving this device
No recalls on record reference this clearance.