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ReNew 3946

by Microline Surgical, Inc.

Ref 3946

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

6 Sep 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K201884

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3841767CE01 Date6 Sep 2026IssuedStatusActive expires 6 Sep 2031
United StatesGUDID listing GUDID Number00811099013815 UDI-DI Date20 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK201884 Date21 Oct 2020IssuedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3841767CE01 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 Sep 2026
    Expires
    6 Sep 2031

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Renew XR Handpiece, Ratcheted, 25cm EUDAMED
ReNew GUDID
Generic name
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device name
ReNew Handpieces
Model / Ref / Catalog
3946
Primary DI / UDI-DI
00811099013815
Basic UDI-DI
081109901DOC003S9
Direct marketing DI
00811099013815
510(k) Number
FDA product code
GEI
EMDN code
L1203 Laparoscopic and thoracoscopic surgery manipulators, reusable
GMDN term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

Cleared under the same submission (K201884)

Other devices from Microline Surgical, Inc.

  • ReNew 3412

    Class II

  • ReNew 3362

    Class II

  • ReNew 3411

    Class II

  • Microline 132-135D

    Class II

  • ReNew 3322

    Class II

  • ReNew 3709

    Class II

See all devices from Microline Surgical, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date

Other properties (19)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No