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Noetix Surgical Extraction System

by Noetix, Inc.

510(k) K881635

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 NumberK881635 Date1 Jul 1988ClearedStatusActive

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  • Withdrawn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
Noetix(R) Surgical Extraction(Tm) System
510(k) Number
FDA Product Code
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a unit for phacofragmentation, used in ophthalmic procedures. It is classified as a Class II medical device under FDA regulation number 886.4670.

The system received FDA 510(k) clearance (K881635) on July 1, 1988, as substantially equivalent to a predicate device. It is manufactured by Noetix, Inc. and is intended for use in ophthalmic surgical settings.

Other devices from Noetix, Inc.

Questions

AI-generated answers, 1 Oct 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 NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM used for?

    The device is a unit for phacofragmentation, used in ophthalmic procedures to fragment the lens during cataract surgery, as specified in its FDA 510(k) clearance.

  • What regulatory pathway was used for the NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM?

    The system received FDA 510(k) clearance (K881635) on July 1, 1988, as substantially equivalent to a predicate device under Class II regulation 886.4670.

  • Who manufactures the NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM and where is it located?

    The device is manufactured by Noetix, Inc., with its address listed as 5602 Elmwood Ave., Suite 122, Elmwood Park, Indianapolis, IN 46203, United States.