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Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted

by Transenterix, Inc.

510(k) K122299

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 NumberK122299 Date25 Oct 2012ClearedStatusActive

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  • Withdrawn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
Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical Instruments, Flexible Monopolar
510(k) Number
FDA Product Code
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted is a laparoscopic tool designed for use with the Spider Single Port Device. This device functions as a grasper to facilitate surgical procedures.

These instruments are supplied as disposable, single-use tools. The device has received FDA 510(k) clearance under K122299.

Other devices from Transenterix, Inc.

See all devices from Transenterix, Inc. →

Questions

AI-generated answers, 25 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 intended use of the Spider Flexible Monopolar Grasper?

    This device is a laparoscopic tool designed to function as a grasper during surgical procedures. It is specifically engineered for compatibility with the Spider Single Port Device.

  • Is the Spider Flexible Monopolar Grasper reusable?

    No, these instruments are supplied as disposable, single-use tools. They are intended to be used for a single procedure and then discarded to ensure patient safety and maintain device integrity.

  • What is the regulatory status of this surgical instrument?

    The Spider Surgical Flexible Monopolar Grasper Wavy Ratcheted has received FDA 510(k) clearance under K122299, confirming it has been found substantially equivalent to predicate devices.