KSEA VAPORIZATION ELECTRODES
Device Facts
| Record ID | K961702 |
|---|---|
| Device Name | KSEA VAPORIZATION ELECTRODES |
| Applicant | Karl Storz Endoskop GmbH |
| Product Code | FAS · Gastroenterology, Urology |
| Decision Date | Aug 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis).
Device Story
Manually operated, single-use endoscopic electrodes; accessory to resectoscopes; used for cutting prostate tissue, superficial bladder tumors, and cauterizing minor bleeding (hemostasis). Operated by surgeons in clinical/surgical settings. Device provides mechanical access to surgical site; electrical energy delivery for tissue vaporization/hemostasis. Benefits include precise tissue removal and bleeding control during urological procedures.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Manually operated, single-use endoscopic instruments; designed as resectoscope accessories; body contact materials with established medical history; provided sterile.
Indications for Use
Indicated for patients requiring resection of prostate tissue or superficial bladder tumors, and for hemostasis of minor bleeding in the prostate and bladder.
Regulatory Classification
Identification
An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
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