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Ethicon

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref CDH25BRef CDH21B510(k) K101990

by Ethicon Endo-Surgery, LLC

Identity

Trade Name
ETHICON EUDAMED
Device Name
ETHICON Circular Stapler EUDAMED
Model / Reference
CDH25B EUDAMED
CDH21B EUDAMED

Identifiers

Primary DI / UDI-DI
10705036022886 EUDAMED
10705036022879 EUDAMED
Basic UDI-DI
0705036a000987H EUDAMED
510(k) Number
K101990 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
EMDN Code
H0202020201 SINGLE-USE CURVED CIRCULAR STAPLERS FOR OPEN SURGERY EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Market of Registration
Belgium EUDAMED
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Ethicon by Ethicon Endo-Surgery, LLC — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC
EUDAMED SRN
US-MF-000013107
Authorised Representative
Johnson & Johnson Medical GmbH DE-AR-000007712

Sources (3)

  • EUDAMED dd43aa19-69a3-49ed-a173-17864046ae75 61 fields · synced Jul 18, 2026
  • EUDAMED dec9ab43-39a1-4131-a959-be5a805ce4d7 61 fields · synced May 18, 2026
  • FDA 510(k) K101990 24 fields · synced May 18, 2026