PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1
Device Facts
| Record ID | K911104 |
|---|---|
| Device Name | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 |
| Applicant | Hgm Medical Laser Systems, Inc. |
| Product Code | FEX · Gastroenterology, Urology |
| Decision Date | Jun 11, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5090 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.
