OLYMPUS FB SERIES BIOPSY FORCEPS
Device Facts
| Record ID | K962555 |
|---|---|
| Device Name | OLYMPUS FB SERIES BIOPSY FORCEPS |
| Applicant | Olympus America, Inc. |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Jul 30, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
Indications for Use
The Olympus biopsy forceps are intended to be used for the collection of tissue samples under endoscopic observation.
Device Story
Reusable biopsy forceps; used with bronchoscopes for tissue sampling in respiratory tract; operated by physicians during endoscopic observation; device collects tissue specimens for diagnostic analysis; mechanical operation; manual actuation.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Reusable biopsy forceps; mechanical actuation; designed for use with bronchoscopes; materials and design consistent with predicate devices.
Indications for Use
Indicated for tissue collection within respiratory organs during endoscopic procedures.
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.
Predicate Devices
- Olympus FB Series of Reusable Biopsy Forceps (K955065)
