OLYMPUS BASKET GRASPERS (UROLOGY)
Device Facts
| Record ID | K961611 |
|---|---|
| Device Name | OLYMPUS BASKET GRASPERS (UROLOGY) |
| Applicant | Olympus America, Inc. |
| Product Code | OCZ · Gastroenterology, Urology |
| Decision Date | Jul 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Olympus basket graspers are intended to be used to retrieve foreign bodies, excised tissue, etc., endoscopically.
Device Story
Flexible shaft grasping device with proximal control handle; used under endoscopic visualization. Operator actuates handle to open/close distal basket for retrieval of foreign bodies or excised tissue. Used in clinical/endoscopic settings by physicians. Facilitates minimally invasive removal of objects/tissue during endoscopic procedures.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Flexible shaft with proximal control handle; mechanical actuation of distal basket. Class II device per 21 CFR 876.1500.
Indications for Use
Indicated for endoscopic retrieval of foreign bodies and excised tissue in patients requiring urological or endoscopic intervention.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
Predicate Devices
- Olympus FG Basket Grasper Forceps (K955063)
Related Devices
- K962378 — OLYMPUS FG-45/46-1 GRASPING FORCEPS · Olympus America, Inc. · Aug 2, 1996
- K962474 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) · Olympus America, Inc. · Dec 20, 1996
- K962485 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) · Olympus America, Inc. · Aug 20, 1996
- K962533 — OLYPUS FG SERIES GRASPING FORCEPS · Olympus America, Inc. · Aug 9, 1996
- K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE · United States Endoscopy Group, Inc. · Oct 4, 1996
