FDA Product Code
FDA Product Code FAD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4620
510(k) Clearances — 122 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K863492 | METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. | Surgitek | 1986-12-18 | Traditional | PDF ↗ |
| K862539 | SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE | Mentor Corp. | 1986-09-09 | Traditional | PDF ↗ |
| K861478 | BARD DOUBLE PIGTAIL URETERAL STENT | C.R. Bard, Inc. | 1986-05-15 | Traditional | PDF ↗ |
| K860267 | MARDIS DANGLER URETERAL STENT SET | Van-Tec, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K854908 | UROFLEX | Angiomed U.S., Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K860055 | MENTOR SINGLE COIL URINARY DIVERSION STENT SET | Mentor Corp. | 1986-03-11 | Traditional | PDF ↗ |
| K854862 | CURITY URETERAL STENT | The Kendal Co. | 1986-02-10 | Traditional | PDF ↗ |
| K852389 | URETERAL STENT | American Medical Systems, Inc. | 1985-09-05 | Traditional | PDF ↗ |
| K851870 | MENTOR UNIVERSAL URETERAL STENT SET | Mentor Corp. | 1985-07-02 | Traditional | PDF ↗ |
| K850175 | MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S | Mentor Corp. | 1985-03-07 | Traditional | PDF ↗ |
| K850176 | MENTOR DBL-COIL INDWELLING POLYURETHANE URETERAL- | Mentor Corp. | 1985-02-28 | Traditional | PDF ↗ |
| K833782 | SURGITEK ALL SILICONE INFECTION DOUBJ | Surgitek | 1984-04-02 | Traditional | PDF ↗ |
| K834401 | URETERAL DOUBLE PIGTAIL STENT | Hobbs Medical, Inc. | 1984-03-22 | Traditional | PDF ↗ |
| K840059 | SILITEK URINARY DIVERSION STENT | Surgitek | 1984-02-04 | Traditional | PDF ↗ |
| K832915 | URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN | Surgitek | 1983-10-14 | Traditional | PDF ↗ |
| K831857 | SURGITEK PERCUTANEOUS ARNEGRADE SILITEK | Medical Engineering Corp. | 1983-08-11 | Traditional | PDF ↗ |
| K831446 | SURGITEK NEPHROSTENT KIT | Mec/Surgitek Products | 1983-06-22 | Traditional | PDF ↗ |
| K823487 | BARD URETERAL STENT | C.R. Bard, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K830884 | SURGITEKS PERCUTANEOUS ANTEGRADE ALL - | Medical Engineering Corp. | 1983-05-09 | Traditional | PDF ↗ |
| K820870 | URETERAL STANT SET | Van-Tec, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K800109 | SURGITEK URINARY DIVERSION STENT | Medical Engineering Corp. | 1980-02-26 | Traditional | PDF ↗ |
| K781641 | SURGITEK DOUBLE J URETEROL STENT | Medical Engineering Corp. | 1978-12-07 | Traditional | PDF ↗ |
Product code FAD · Class II · Gastroenterology, Urology. Data: openFDA.