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Spinewand Surgical Device

by Arthrocare Corp. 2 variants

510(k) K100353

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 · Special NumberK100353 Date13 May 2010ClearedStatusActive

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Spinewand Surgical Device is a bipolar, high-frequency electrosurgical device designed for the ablation, coagulation, and decompression of disc material. It is indicated for use in treating symptomatic patients with contained herniated discs.

This single-use device is regulated as a Class 2 electrosurgical cutting and coagulation instrument under FDA 510(k) clearance K100353. It is manufactured by Arthrocare Corp. and is classified under product code GEI.

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