Product Code: NWS
FDA class 2
21 CFR 876.1500
Kit, Choledochoscope, Flexible And Rigid
Gastroenterology, Urology
The Kit, Choledochoscope, Flexible and Rigid (product code NWS) is a diagnostic and surgical convenience kit used for direct visualization of the bile duct (common bile duct) via both flexible and rigid choledochoscopes, regulated under 21 CFR 876.1500 within the Gastroenterology and Urology specialty. It is classified as FDA Class 2 and requires 510(k) clearance. The device has no implant or life-sustaining designations.
510(k)s
1
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
—
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Basic Information
- Product Code
- NWS
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Flexible and Rigid Choledochoscope Kit
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K810503 | FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE | Apr 03, 1981 | Substantially Equivalent | Olympus Corp. |