FDA Product Code
FDA Product Code FCH — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4730
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K882673 | SIGMA 1 WOBBLER BIOPSY KIT | Kontron Instruments, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K852105 | MANAN UBK ULTRASONIC GUIDED BIOPSY KIT | Manan Manufacturing Co., Inc. | 1985-06-18 | Traditional | PDF ↗ |
Product code FCH · Class I · Gastroenterology, Urology. Data: openFDA.