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Top Cut M

by H.S. Hospital Service SpA 5 variants

Ref TOP 1416MModel TOP CUT

Top Cut M (TOP 1416M) is a device classified as Class IIa in the EU and Class II in the US made by H.S. Hospital Service SpA, registered in EUDAMED on 21 Aug 2026 (Basic UDI-DI B-08033003347386), cleared under FDA 510(k) K021525 on 12 Jul 2002 and listed in FDA GUDID since 31 Mar 2022 (UDI-DI 08033003347386), active as of 23 Oct 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K021525

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08033003347386 Basic UDI-DI 08033003347386UDI-DIDate21 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033003347386 UDI-DI Date31 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK021525 Date12 Jul 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08033003347386 registered 21 Aug 2026 Active
  • FDA 510(k) K021525 decided 12 Jul 2002 Active
  • FDA GUDID UDI-DI 08033003347386 listed 31 Mar 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K021525
  2. Listed FDA GUDID 08033003347386
  3. Registered EUDAMED B-08033003347386

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Top Cut
Generic name
Side-notch biopsy gun handpiece/needle
Model / Ref / Catalog
TOP CUT, TOP 1416M, TOP CUT M
Primary DI / UDI-DI
08033003347386
Basic UDI-DI
B-08033003347386
510(k) Number
FDA product code
FCG
EMDN code
A0102010101 Shearing biopsy needles
GMDN term
Side-notch biopsy gun handpiece/needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 160 Millimeter
Needle Gauge — 14 Gauge

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TOP CUT
TOP 1416M
GUDID
TOP CUT M
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Side-notch biopsy gun handpiece/needle

Cleared under the same submission (K021525)

and 5 more cleared under K021525

Similar devices in this category

Other devices filed under SHEARING BIOPSY NEEDLES AND KITS.

Other devices from H.S. Hospital Service SpA

  • Trap Easy

    Class II

  • Ecojekt

    Class I

  • Bmn I Type

    Class II

  • Introducer Needle

    Class I

See all devices from H.S. Hospital Service SpA →

Properties

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