FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pristine Scope
K Number: K193161
·
Decision Apr 21, 2020
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
3
Review Days
158
Basic Information
- Device Name
- Pristine Scope
- K Number
- K193161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pristine Surgical
- Date Received
- November 15, 2019
- Decision Date
- April 21, 2020
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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