FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ensizor Endoscopic Scissors
K Number: K150939
·
Decision Jun 8, 2015
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
3
Review Days
62
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Ensizor Endoscopic Scissors
- K Number
- K150939
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Slater Endoscopy, LLC
- Date Received
- April 7, 2015
- Decision Date
- June 8, 2015
- Product Code
- OCZ
- 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCZ), ordered by most recent decision date.
KARL STORZ Endoscopic Accessories for Urology
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Grasping Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Grasping Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENSIZOR ENDOSCOPIC SCISSORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOSCOPIC SUTURE CUTTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology