Olympus FG Series Grasping Forceps
510(k) K962533
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962533 | Date9 Aug 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Olypus Fg Series Grasping Forceps
- 510(k) Number
- FDA Product Code
- EOQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.4680
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Olympus FG Series Grasping Forceps are classified as graspers (Device Type: EOQ) and are designed for endoscopic use in otolaryngology procedures. These forceps provide secure tissue manipulation and retrieval of foreign bodies or excised tissue, featuring configurations such as a 3-prong tripod (e.g., FG-600U) or a V-shape (e.g., FG-25C-1) to optimize grasping capability while minimizing tissue trauma.
The FG Series is available in both single-use (e.g., FG-600U) and reusable (e.g., FG-25C-1) variants, with models like the FG-25C-1 intended for fine tissue handling and foreign object retrieval. Supplied sterile or non-sterile based on model, these forceps are intended for use in MRI-safe environments and are regulated under FDA 510(k) clearance (K962533). Storage and handling comply with standard endoscopic instrument protocols.
Other devices from Olympus America, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of endoscopic procedures are these forceps primarily used for in otolaryngology?
The Olympus FG Series Grasping Forceps are designed specifically for otolaryngology procedures, where they assist in securely manipulating tissue and retrieving foreign bodies or excised material. Their configurations—such as the 3-prong tripod (e.g., FG-600U) or V-shape (e.g., FG-25C-1)—help minimize tissue trauma during delicate manipulations like foreign body removal or fine tissue handling.
Are these forceps safe to use in an MRI environment, and how does that affect their selection?
Yes, the Olympus FG Series Grasping Forceps are explicitly labeled as MRI-safe, making them suitable for use in MRI environments. This feature is particularly important in otolaryngology when imaging or monitoring is required during or after the procedure, as it ensures compatibility without interference or safety risks.
How do I determine whether a specific FG Series model is single-use or reusable, and what does that mean for my workflow?
The FG Series includes both single-use models (e.g., FG-600U) and reusable models (e.g., FG-25C-1). Single-use models are pre-sterilized and intended for one-time use, simplifying workflow by eliminating reprocessing steps. Reusable models require cleaning, disinfection, and sterilization between uses, which may impact your facility’s logistics and turnaround time but can be cost-effective for high-volume procedures.
What should I consider when storing these forceps to maintain their performance and sterility?
Storage follows standard endoscopic instrument protocols. Single-use models should be stored in their original packaging until use to preserve sterility, while reusable models must be cleaned, disinfected, and sterilized before storage. Both variants should be kept in a dry, clean environment away from direct sunlight or extreme temperatures to prevent degradation or contamination.
How do I know which FG Series model is best suited for retrieving small foreign objects versus larger tissue samples?
The FG-600U (3-prong tripod design) is ideal for retrieving small foreign objects due to its precise grip and reduced tissue trauma, while the FG-25C-1 (V-shape) is better suited for fine tissue handling and larger excised samples. The choice depends on the specific procedural needs—smaller, delicate objects benefit from the FG-600U’s controlled grasp, whereas bulkier samples may require the broader V-shape of the FG-25C-1.