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Mammotome revolve MG08B

by Devicor Medical Products, Inc.

Ref MG08B

Mammotome revolve MG08B is a device classified as Class I in the EU and Class II in the US made by Devicor Medical Products, Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 08419111AD02E000003322TA), cleared under FDA 510(k) K943863 on 29 Dec 1994 and listed in FDA GUDID since 4 Feb 2022 (UDI-DI 00841911100782), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K943863

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08419111AD02E000003322TA Basic UDI-DI 00841911100782UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841911100782 UDI-DI Date4 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK943863 Date29 Dec 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08419111AD02E000003322TA registered 7 May 2026 Active
  • FDA 510(k) K943863 decided 29 Dec 1994 Active
  • FDA GUDID UDI-DI 00841911100782 listed 4 Feb 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K943863
  2. Listed FDA GUDID 00841911100782
  3. Registered EUDAMED 08419111AD02E000003322TA

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  • Withdrawn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
Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMED
Mammotome revolve GUDID
Generic name
Needle guide, single-use
Model / Ref / Catalog
MG08B
Primary DI / UDI-DI
00841911100782
Basic UDI-DI
08419111AD02E000003322TA
510(k) Number
FDA product code
IYN
EMDN code
A019012 Breast nodules and other structures localisation needles and systems
GMDN term
Needle guide, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1550
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Needle Gauge — 8 Gauge

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Needle guide, single-use

Cleared under the same submission (K943863)

and 8 more cleared under K943863

Similar devices in this category

Other devices filed under BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS.

Other devices from Devicor Medical Products, Inc.

See all devices from Devicor Medical Products, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)