Skip to content

Single Use Circular Stapler CSB26

by Golden Stapler Surgical Co., Ltd

Ref CSB26

Single Use Circular Stapler CSB26 is a device classified as Class IIb in the EU and Class II in the US made by Golden Stapler Surgical Co., Ltd, registered in EUDAMED on 26 May 2026 (Basic UDI-DI B-06946912216037), cleared under FDA 510(k) K162707 on 14 Jul 2017 and listed in FDA GUDID since 13 Jun 2019 (UDI-DI 06946912216037), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K162707

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/MDD EUDAMED NumberB-06946912216037 Basic UDI-DI 06946912216037UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06946912216037 UDI-DI Date13 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK162707 Date14 Jul 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06946912216037 registered 26 May 2026 Active
  • FDA 510(k) K162707 decided 14 Jul 2017 Active
  • FDA GUDID UDI-DI 06946912216037 listed 13 Jun 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K162707
  2. Listed FDA GUDID 06946912216037
  3. Registered EUDAMED B-06946912216037

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  • Withdrawn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
Golden Stapler EUDAMED
Single Use Circular Stapler GUDID
Generic name
Intraluminal circular stapler, single-use
Model / reference
CSB26
Primary DI / UDI-DI
06946912216037
Basic UDI-DI
B-06946912216037
510(k) Number
FDA product code
GDW
EMDN code
H0202020201 Single-use curved circular staplers for open surgery
GMDN term
Intraluminal circular stapler, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4750
EU registration type
Legacy device (under a directive)
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution

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: Intraluminal circular stapler, single-use

Cleared under the same submission (K162707)

and 8 more cleared under K162707

Similar devices in this category

Other devices filed under SINGLE-USE CURVED CIRCULAR STAPLERS FOR OPEN SURGERY.

Other devices from Golden Stapler Surgical Co., Ltd

See all devices from Golden Stapler Surgical Co., Ltd →

Properties

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