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Percudisc PLDD Delivery System/Procedure Kit

by Percudisc, Inc.

510(k) K920673

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)SESK Substantially Equivalent — Kit · Traditional NumberK920673 Date13 Aug 1992ClearedStatusActive

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESK Substantially Equivalent — Kit

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 Percudisc PLDD Delivery System/Procedure Kit is a medical device used for Percutaneous Laser Disc Decompression (PLDD) procedures. This system is designed to deliver laser energy for the treatment of intervertebral disc conditions. The kit contains the necessary components to perform the PLDD procedure, which involves the percutaneous insertion of a laser fiber into the affected disc space.

The Percudisc PLDD Delivery System/Procedure Kit is supplied as a complete kit for single-use procedures. The device is not MRI compatible and requires appropriate storage conditions as specified by the manufacturer. The Percudisc PLDD Delivery System/Procedure Kit (K920673) received FDA 510(k) clearance on August 13, 1992, and is classified under product code GEX.

Other devices from Percudisc, Inc.

Questions

AI-generated answers, 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.

  • What is the Percudisc PLDD Delivery System/Procedure Kit used for?

    The Percudisc PLDD Delivery System/Procedure Kit is a medical device designed for Percutaneous Laser Disc Decompression (PLDD) procedures. It delivers laser energy for the treatment of intervertebral disc conditions through percutaneous insertion of a laser fiber into the affected disc space.

  • How is the Percudisc PLDD Delivery System supplied?

    The Percudisc PLDD Delivery System/Procedure Kit is supplied as a complete kit for single-use procedures. It contains all necessary components to perform the PLDD procedure, but is not MRI compatible and requires appropriate storage conditions as specified by the manufacturer.

  • What is the regulatory status of the Percudisc PLDD Delivery System?

    The Percudisc PLDD Delivery System/Procedure Kit (K920673) received FDA 510(k) clearance on August 13, 1992, and is classified under product code GEX. It is intended for single-use procedures only.

  • What components are included in the Percudisc PLDD Delivery System/Procedure Kit?

    The Percudisc PLDD Delivery System/Procedure Kit contains all necessary components to perform the Percutaneous Laser Disc Decompression (PLDD) procedure, which includes the laser delivery system and accessories for percutaneous insertion into the affected disc space.