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LEEP Radius Electrode

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref S1004Model B0312Ref R2020Ref R1010Ref R1007Ref N2512Ref V1004Ref R2008Ref S1010Ref R1515Ref R2015Ref N2555Ref N0550Ref B0512Ref R1505Ref B0555

by CooperSurgical, Inc.

Identity

Trade Name
LEEP Radius Electrode FDA UDI
LEEP Micro Needle Electrode FDA UDI
LEEP Square Condyloma Electrode FDA UDI
LEEP Vaginal Electrode FDA UDI
LEEP Ball Electrode FDA UDI
LEEP Square Electrode FDA UDI
LEEP Macro Needle Electrode FDA UDI
Generic Name
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Device Name
LEEP Ball Electrode EUDAMED
LEEP Radius Electrode;1.5cm x 0.5cm; 12cm Shaft FDA UDI
LEEP Radius Electrode; 2.0cm x 0.8cm; 12cm Shaft FDA UDI
LEEP Micro Needle Electrode with 5mm Needle Electrode and 5.5cm Shaft FDA UDI
LEEP Radius Electrode; 1.5cm x 1.5cm; 12cm Shaft FDA UDI
LEEP Square Condyloma Electrode 5.5cm Shaft; 15 Degree Bend FDA UDI
LEEP Vaginal Electrode; 8 cm Shaft; 15 Degree Bend FDA UDI
LEEP Ball Electrode; 5mm Diameter; 12cm Shaft FDA UDI
LEEP Ball Electrode; 5mm Diameter; 5.5cm Shaft FDA UDI
LEEP Micro Needle Electrode with 8mm Needle Electrode and 12cm Shaft FDA UDI
LEEP Radius Electrode; 1.0cm x 1.0cm; 12cm Shaft FDA UDI
LEEP Radius Electrode 1.0cm x 0.7cm; 12cm Shaft FDA UDI
LEEP Square Electrode; 12cm Shaft FDA UDI
LEEP Radius Electrode; 2.0cm x 1.5cm; 12cm Shaft FDA UDI
LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft FDA UDI
LEEP Ball Electrode; 3mm Diameter and 12cm Shaft FDA UDI
LEEP Radius Electrode; 2.0cm x 2.0cm; 12cm Shaft FDA UDI
Model / Reference
R1505 EUDAMEDFDA UDI
R2008 EUDAMEDFDA UDI
N2555 EUDAMEDFDA UDI
R1515 EUDAMEDFDA UDI
S1004 EUDAMEDFDA UDI
V1004 EUDAMEDFDA UDI
B0512 EUDAMEDFDA UDI
B0555 EUDAMEDFDA UDI
N2512 EUDAMEDFDA UDI
R1010 EUDAMEDFDA UDI
R1007 EUDAMEDFDA UDI
S1010 EUDAMEDFDA UDI
R2015 EUDAMEDFDA UDI
N0550 EUDAMEDFDA UDI
B0312 EUDAMEDFDA UDI
R2020 EUDAMEDFDA UDI
Description
LEEP Radius Electrode;1.5cm x 0.5cm; 12cm Shaft FDA UDI
LEEP Radius Electrode; 2.0cm x 0.8cm; 12cm Shaft FDA UDI
LEEP Micro Needle Electrode with 5mm Needle Electrode and 5.5cm Shaft FDA UDI
LEEP Radius Electrode; 1.5cm x 1.5cm; 12cm Shaft FDA UDI
LEEP Square Condyloma Electrode 5.5cm Shaft; 15 Degree Bend FDA UDI
LEEP Vaginal Electrode; 8 cm Shaft; 15 Degree Bend FDA UDI
LEEP Ball Electrode; 5mm Diameter; 12cm Shaft FDA UDI
LEEP Ball Electrode; 5mm Diameter; 5.5cm Shaft FDA UDI
LEEP Micro Needle Electrode with 8mm Needle Electrode and 12cm Shaft FDA UDI
LEEP Radius Electrode; 1.0cm x 1.0cm; 12cm Shaft FDA UDI
LEEP Radius Electrode 1.0cm x 0.7cm; 12cm Shaft FDA UDI
LEEP Square Electrode; 12cm Shaft FDA UDI
LEEP Radius Electrode; 2.0cm x 1.5cm; 12cm Shaft FDA UDI
LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft FDA UDI
LEEP Ball Electrode; 3mm Diameter and 12cm Shaft FDA UDI
LEEP Radius Electrode; 2.0cm x 2.0cm; 12cm Shaft FDA UDI

Identifiers

Primary DI / UDI-DI
00888937010787 EUDAMEDFDA UDI
00888937010817 EUDAMEDFDA UDI
00888937010756 EUDAMEDFDA UDI
00888937010800 EUDAMEDFDA UDI
00888937010862 EUDAMEDFDA UDI
00888937010893 EUDAMEDFDA UDI
00888937010916 EUDAMEDFDA UDI
00888937010718 EUDAMEDFDA UDI
00888937010749 EUDAMEDFDA UDI
00888937010770 EUDAMEDFDA UDI
00888937010763 EUDAMEDFDA UDI
00888937010886 EUDAMEDFDA UDI
00888937010831 EUDAMEDFDA UDI
00888937010725 EUDAMEDFDA UDI
00888937010909 EUDAMEDFDA UDI
00888937010848 EUDAMEDFDA UDI
Basic UDI-DI
0888937TD018ZN EUDAMED
510(k) Number
K905747 FDA UDI
FDA Product Code
HGI FDA UDI
EMDN Code
K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
GMDN Term
Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
884.4120 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Depth — 0.4 Centimeter FDA UDI
Width — 1.0 Centimeter FDA UDI
Depth — 1.0 Centimeter FDA UDI

Category: Open-surgery electrosurgical electrode, monopolar, single-use

LEEP Radius Electrode by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.

Cleared under the same submission

K905747 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (32)

  • FDA UDI 3d069ecb-bc13-40f7-90c6-d331cf3c6f95 34 fields · synced Sep 18, 2026
  • FDA UDI c7f399ee-7985-4453-9e35-8e6ced0e57a1 34 fields · synced May 29, 2026
  • FDA UDI 27a05eff-e78f-4b07-b113-1dfefcc8b230 35 fields · synced May 29, 2026
  • FDA UDI 5864524f-ea23-443a-ac3a-005d277ba2cc 34 fields · synced May 29, 2026
  • FDA UDI c1ea6585-a119-4d24-ab0d-78af5a3a3f4c 35 fields · synced May 30, 2026
  • FDA UDI 65fd23bb-224b-4e9f-9e3c-2a532043cf3d 35 fields · synced May 30, 2026
  • FDA UDI 1ea08f94-75dc-4f0f-b705-19d582baa76b 34 fields · synced May 30, 2026
  • FDA UDI 0ac261ad-1c5f-4f11-9aef-c671554e53cb 34 fields · synced May 30, 2026
  • FDA UDI 12e0d15a-5626-4b73-af85-d01f760bd5fd 35 fields · synced May 30, 2026
  • FDA UDI fa446936-ca90-4f99-b03b-61d3c8a717aa 34 fields · synced May 30, 2026
  • FDA UDI 0ca36957-7822-45b4-88cf-844070404ce3 34 fields · synced May 30, 2026
  • FDA UDI d2642f93-de71-44ac-bbc9-1f5511ef57e3 35 fields · synced May 30, 2026
  • FDA UDI 701e15b9-3815-4d6f-b27b-70dfef7095fb 34 fields · synced May 30, 2026
  • FDA UDI c973c696-b400-4d39-9d19-94f54def83bb 35 fields · synced May 30, 2026
  • FDA UDI 404d6064-dce8-488b-8459-5b8991227854 34 fields · synced May 30, 2026
  • FDA UDI a0129eba-2f29-4557-8811-3b0f7de1f331 34 fields · synced May 30, 2026
  • EUDAMED 490f67a4-d8ba-4dac-9b01-9b99855190d4 61 fields · synced Jul 9, 2026
  • EUDAMED 01b54d78-1a48-4238-a1e0-aed8bcb4f23c 61 fields · synced Jul 9, 2026
  • EUDAMED d2faca60-9a5b-41b6-bc3d-524826b7318f 61 fields · synced Jul 9, 2026
  • EUDAMED a5e58bbb-3aa7-4d78-aa95-23dd6ddc769b 61 fields · synced Jul 10, 2026
  • EUDAMED 2403d885-7b88-4c85-9f91-1dbf24381996 61 fields · synced Jul 11, 2026
  • EUDAMED 4dd6d097-afd3-4a2c-ad68-40e59e274d68 61 fields · synced Jul 14, 2026
  • EUDAMED 0c2d331a-4d3e-4df4-ab6c-3030037a869f 61 fields · synced Jul 14, 2026
  • EUDAMED f2c88750-6e6a-4951-899c-df379ea9ad7d 61 fields · synced Jul 15, 2026
  • EUDAMED d31134de-daa8-469b-bd41-6bc20c2d2bdc 61 fields · synced Jul 17, 2026
  • EUDAMED 3426a739-c358-4a63-88fd-0439c20110d9 61 fields · synced Jul 23, 2026
  • EUDAMED fa6dc751-7b77-41e2-981c-4812a4fe88c1 61 fields · synced Jul 27, 2026
  • EUDAMED 34bfb8e9-b492-48b6-a9b8-4561a190208a 61 fields · synced Jul 28, 2026
  • EUDAMED d00e9893-5b9c-4216-8473-71e3c6eb2665 61 fields · synced Jul 31, 2026
  • EUDAMED efef9a3b-d9b4-49cc-b7c2-4664d18e7873 61 fields · synced Jul 31, 2026
  • EUDAMED 9277d9c0-aa3a-4438-b441-95bf298d6e96 61 fields · synced Aug 1, 2026
  • EUDAMED 8fc2b0a5-7975-4332-b107-375706e4b010 61 fields · synced Sep 18, 2026