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Olympus FG Series Grasping Forceps

by Olympus America, Inc.

510(k) K962533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK962533 Date9 Aug 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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See all devices from Olympus America, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.