FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Zimmon Needle Knife Papillotome
K Number: K171993
·
Decision Aug 17, 2017
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
180
Applicant Total
4
Review Days
45
Basic Information
- Device Name
- Zimmon Needle Knife Papillotome
- K Number
- K171993
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilson-Cook Medical, Inc. / Cook Endoscopy
- Date Received
- July 3, 2017
- Decision Date
- August 17, 2017
- Product Code
- KNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Wilson-Cook Medical, Inc. / Cook Endoscopy
| K Number | Device Name | ||
|---|---|---|---|
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Dec 19, 2019 | Substantially Equivalent |
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| K171607 | Bronchi and Gastrointestinal Cytology Brush | Jul 31, 2017 | Substantially Equivalent |