KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
Device Facts
| Record ID | K960791 |
|---|---|
| Device Name | KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Mar 11, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures.
Device Story
Manually operated, reusable surgical device; consists of bronchoscope tube with cutting loop and high-frequency cord connection. Used in ENT endoscopic procedures; operated by physicians. Device delivers high-frequency electrical current to excise tissue pathologies in bronchi or esophagus. Benefits include precise tissue removal during endoscopic surgery.
Clinical Evidence
Bench testing only.
Technological Characteristics
Materials: surgical grade stainless steel and tungsten. Energy source: high-frequency electrical current. Form factor: bronchoscope tube with cutting loop. Reusable. Manual operation.
Indications for Use
Indicated for removal of bronchial and/or esophageal pathologies in adult and pediatric patients during ENT endoscopic surgical procedures using high-frequency electrical current.
Regulatory Classification
Identification
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.
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