Coag Endo-Dissector

The Coag Endo-Dissector is a monopolar electrosurgical instrument for dissection and hemostasis using flexible endoscopes • branches for blunt dissection of tissue • good coagulation…

Registry build 21.09.26

The Coag Endo-Dissector is a monopolar electrosurgical instrument for dissection and hemostasis using flexible endoscopes • branches for blunt dissection of tissue • good coagulation capabilities between branches • rotatable flexible shaft for precise alignment of tip • curved grasper for precise targeting of the tissue • teeth provide secure grasping of the bleeding area

3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (1), Beijing (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code KGE
Manufacturer City Province Registered as Device types
Micro-Tech (Nanjing) Co., Ltd. Nan Jing Jiangsu Contract manufacturer 49
Beijing Zksk Technology Co., Ltd. Beijing Beijing Contract manufacturer 38
Hangzhou AGS MedTech Co., Ltd. Hangzhou Zhejiang Repacker / relabeller 19

Record

Regulatory record for Coag Endo-Dissector
Listed by Ovesco Endoscopy AG, Germany
FDA product code KGE
Device type Forceps, Biopsy, Electric
Device class Class 2
Regulation 21 CFR 876.4300
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K141794
Record published 2016-09-16
Record revised 2019-10-31 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Coag Endo-Dissector
Catalogue number Size Status
165 cm working length 165 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Forceps, Biopsy, Electric Karl Storz GmbH & Co. KG 32
Zksk Beijing Zksk Technology Co., Ltd. 16
Fujifilm Fujifilm Corporation 15
Fujifilm Diathermic Slitter (FlushKnife) Fujifilm Corporation 13
Forceps, Biopsy, Electric Hangzhou AGS MedTech Co., Ltd. 12
Halyard Avanos Medical, Inc. 9
Single Use Electrosurgical Hemostatic Forceps Olympus Medical Systems Corp. 7
Disposable HOT Biopsy Forceps Olympus Medical Systems Corp. 6
Biopsy Forcep Avanos Medical, Inc. 6
Ensure(TM) Single-Use Coagulation Forceps Micro-Tech (Nanjing) Co., Ltd. 6
ClearHemograsper Finemedix 5
Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) Co., Ltd. 4

Showing 12 of 31. All products under Forceps, Biopsy, Electric

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K141794 2014-11-19

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer