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Sureform 48230W

by Intuitive Surgical, Inc.

Ref 48230W

Sureform 48230W is a device classified as Class IIb in the EU and Class II in the US made by Intuitive Surgical, Inc., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 08868741228158R), cleared under FDA 510(k) K211997 on 10 Dec 2021 and listed in FDA GUDID since 11 May 2022 (UDI-DI 00886874121924), active as of 7 Nov 2026. 2 FDA recalls are linked to it.

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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211997

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08868741228158R Basic UDI-DI 00886874121924UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886874121924 UDI-DI Date11 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211997 Date10 Dec 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08868741228158R registered 26 Oct 2026 Active
  • FDA 510(k) K211997 decided 10 Dec 2021 Active
  • FDA GUDID UDI-DI 00886874121924 listed 11 May 2022 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1855-2026 FDA Class I initiated 11 Mar 2026

    Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

    • Ongoing Z-0340-2023 FDA Class II initiated 7 Oct 2022

    Potential staple deployment failure and device fragment generation

Timeline

5 dated events

  1. Cleared FDA 510(k) K211997
  2. Listed FDA GUDID 00886874121924
  3. Recall initiated FDA recalls Z-0340-2023
  4. Recall initiated FDA recalls Z-1855-2026
  5. Registered EUDAMED 08868741228158R

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  • Withdrawn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
8 mm SureForm 30 Reload, 30 mm White, 2.5 mm, 4-Row EUDAMED
Sureform GUDID
Generic name
Surgical staple loading unit, non-cutting
Device name
SureForm Stapler Reloads
Model / reference
48230W
Primary DI / UDI-DI
00886874121924
Basic UDI-DI
08868741228158R
FDA product code
NAY, GDW
EMDN code
H02030106 Linear stapler cartridges for videosurgery
GMDN term
Surgical staple loading unit, non-cutting
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
876.1500, 878.4750
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Size
Depth — 30 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Surgical staple loading unit, non-cutting

Cleared under the same submission (K211997)

Similar devices in this category

Other devices filed under LINEAR STAPLER CARTRIDGES FOR VIDEOSURGERY.

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)