Zimmon Needle Knife Papillotome PTW-1E
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Zimmon FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- ZIMMON NEEDLE KNIFE PAPILLOTOME EUDAMEDFDA UDI
- Model / Reference
- PTW-1E EUDAMEDG22717 FDA UDI
- Description
- Zimmon Needle Knife Papillotome FDA UDI
Identifiers
- Catalog Number
- PTW-1E FDA UDI
- Primary DI / UDI-DI
- 00827002227170 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002227170 EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040299 PAPILLOTOMES / SPHINCTEROTOMES - OTHER EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Zimmon Needle Knife Papillotome PTW-1E is a Class IIb endoscopic device designed for cutting and excising tissue, specifically within the biliary or pancreatic ducts. Classified under nomenclature code G03040299, it is an active medical device intended for use in procedures requiring precise tissue removal, such as papillotomy or ductal clearance during endoscopic retrograde cholangiopancreatography (ERCP).
This device is supplied sterile and is intended for single-use only. It is non-implantable and non-reusable, with no latex components. The Zimmon Needle Knife Papillotome PTW-1E is regulated under FDA 510(k) clearance and the Medical Device Directive (MDD), with a Basic UDI of B-00827002227170. Storage and handling must comply with standard sterile instrument protocols to ensure device integrity and safety.
Frequently asked questions
What is the Zimmon Needle Knife Papillotome PTW-1E primarily used for in medical procedures?
The Zimmon Needle Knife Papillotome PTW-1E is designed specifically for cutting and excising tissue within the biliary or pancreatic ducts during endoscopic procedures. It is commonly used for papillotomy or ductal clearance as part of an ERCP (Endoscopic Retrograde Cholangiopancreatography) to ensure precise tissue removal in these critical areas.
Is the Zimmon Needle Knife Papillotome PTW-1E intended for reuse, or is it single-use only?
The Zimmon Needle Knife Papillotome PTW-1E is explicitly intended for single-use only and is not designed for reprocessing or reuse. This classification aligns with standard sterile instrument protocols to maintain safety and integrity for each procedure.
How should the Zimmon Needle Knife Papillotome PTW-1E be stored to ensure its sterility and usability?
Since the device is supplied sterile, storage must comply with standard sterile instrument protocols to preserve its integrity. This includes keeping it in a sealed, protective packaging until use and avoiding exposure to contamination or environmental hazards that could compromise its sterility.
Does the Zimmon Needle Knife Papillotome PTW-1E contain any latex components, and what regulatory pathways does it follow?
The device is latex-free, which reduces the risk of allergic reactions for patients. Regulatory-wise, it follows the FDA 510(k) clearance process (with a decision dated 1997-08-15) and complies with the Medical Device Directive (MDD) in European markets, ensuring its compliance with both U.S. and EU standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972674 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K901443 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K171993 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00827002227170 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wilson-Cook Medical, Inc.
- EUDAMED SRN
- US-MF-000002658
- Authorised Representative
- COOK MEDICAL EUROPE LIMITED IE-AR-000000907
Sources (3)
- EUDAMED 04bafda2-a18c-4e4d-8e75-8aba0432737d 85 fields · synced Oct 6, 2026
- FDA UDI 3f408e24-9793-493e-918a-bd605b5cc0fe 37 fields · synced May 30, 2026
- FDA 510(k) K972674 1 fields · synced May 18, 2026