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Pneumatic Cutter System

by Surgical Laser Technologies, Inc.

510(k) K983050

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 NumberK983050 Date25 Nov 1998ClearedStatusActive

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  • Withdrawn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
ERL
Device Class
Class II
Regulation
21 CFR Part 874.4250
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Pneumatic Cutter System is a surgical drill, ENT (electric or pneumatic) including handpiece, used for cutting and removing soft tissue and drilling bone. It utilizes disposable cutting blades with integrated irrigation and suction ports and operates via pneumatic power to simultaneously suction debris and bone fragments from the operative site.

It is used by surgeons in clinical settings such as the operating room. The device is supplied as a reusable system with disposable blades and is regulated under FDA 510(k) clearance K983050, with product code ERL and classification as a Class II medical device.

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Questions

AI-generated answers, 26 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 Pneumatic Cutter System used for?

    The Pneumatic Cutter System is used for cutting and removing soft tissue and drilling bone in surgical procedures, particularly in ENT applications.

  • How is the Pneumatic Cutter System supplied?

    The device is supplied as a reusable system with disposable cutting blades, allowing for efficient and safe use in clinical settings.

  • Is the Pneumatic Cutter System sterile?

    The device utilizes disposable cutting blades, which are intended to be sterile, but the system itself is reusable and requires proper cleaning and maintenance.

  • What regulatory clearance does the Pneumatic Cutter System have?

    The Pneumatic Cutter System has FDA 510(k) clearance, with a product code of ERL and classification as a Class II medical device.