(42 days)
The Olympus FG series of grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body and excised tissue endoscopically.
The Olympus FG series of grasping forceps are designed for grasping tissue and/or retrieving foreign body and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
This 510(k) summary for the Olympus FG Grasping Forceps (K962533) does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a standard 510(k) summary providing information typically required for premarket notification:
- Device Name, Classification, Predicate Device: Identifies the device and its regulatory context.
- Contact Information: For regulatory inquiries.
- Summary Preparation Date: Date of document creation.
- Statement of Intended Use: Specifies what the device is for.
- Device Description: Explains the physical construction and general operation.
There is no mention of:
- Acceptance criteria (e.g., performance metrics, thresholds for success).
- Any study data demonstrating safety or effectiveness beyond a general statement of intended use and a comparison to a predicate device for substantial equivalence.
- Sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for testing, or training set details.
Conclusion: Based solely on the provided K962533 510(k) summary, it is not possible to answer the requested questions regarding acceptance criteria and performance study details. This type of information is typically found in the full 510(k) submission, not usually in the publicly available summary document, especially for a device from 1996 which would have different regulatory submission requirements than a modern AI-driven device.
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510(k) SUMMARY FOR OLYMPUS FG GRASPING FORCEPS
- Device Name: Olympus FG-4/14/20/21/22/26/32/38/40/##-1 Grasping Forceps (Urology) Common/Usuai Name: Grasping Forceps for bronchoscopy Classification Name: Bronchoscope and Accessories 21 CFR 874.4680, Class II Predicate Device: Olympus pre-Amendment and 510(k) cleared grasping forceps Olympus FG Reusable Grasping Forceps (K955066) for GI Contact Person: Barry Sands Olympus America, Inc. Endoscope Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474 Summary Preparation Date: June 26, 1996 Statement of Intended Use: The Olympus FG series of grasping forceps are intended to be used to grasp tissue and/or retrieve foreign body and excised tissue endoscopically. Device Description: The Olympus FG series of grasping forceps are designed for grasping tissue and/or retrieving foreign body and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
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.(b)
Classification. Class II.