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Flextip Grasper

by Endius, Inc.

510(k) K972450

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 NumberK972450 Date21 Nov 1997ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
EOB
Device Class
Class II
Regulation
21 CFR Part 874.4760
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Flextip Grasper is a medical device classified as a Nasopharyngoscope (Flexible Or Rigid) used in ear, nose, and throat procedures. It is designed to grasp and manipulate tissues during endoscopic examinations or interventions.

The device is supplied as a single-use instrument and is not MRI compatible. It is stored at room temperature and has received FDA 510(k) clearance with the product code EOB, indicating it is substantially equivalent to predicate devices in this class.

Other devices from Endius, Inc.

See all devices from Endius, Inc. →

Questions

AI-generated answers, 23 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 is the Flextip Grasper used for?

    The Flextip Grasper is a medical device classified as a Nasopharyngoscope (Flexible Or Rigid) used in ear, nose, and throat procedures. It is designed to grasp and manipulate tissues during endoscopic examinations or interventions.

  • Is the Flextip Grasper single-use or reusable?

    The Flextip Grasper is supplied as a single-use instrument, meaning it should be used for one procedure only and then discarded. It is not designed for reuse.

  • What are the storage requirements for the Flextip Grasper?

    The Flextip Grasper is stored at room temperature. No special storage conditions are required beyond maintaining standard room temperature conditions.

  • Is the Flextip Grasper MRI compatible?

    No, the Flextip Grasper is not MRI compatible. It should not be used in MRI environments as it may not function properly or could pose safety risks.

  • What regulatory approval does the Flextip Grasper have?

    The Flextip Grasper has received FDA 510(k) clearance with product code EOB, indicating it is substantially equivalent to predicate devices in this class. This clearance was granted on November 21, 1997.