FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARE ENDOSCOPIC SUTURING SYSTEM
K Number: K003102
·
Decision Feb 27, 2001
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
1
Review Days
146
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
- PARE ENDOSCOPIC SUTURING SYSTEM
- K Number
- K003102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pare Surgical, Inc.
- Date Received
- October 4, 2000
- Decision Date
- February 27, 2001
- Product Code
- OCW
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCW), ordered by most recent decision date.
Endomina EZFuse system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SimpleStitch Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MaxTack Motorized Fixation Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MedicloseTM System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OverStitch NXT Endoscopic Suturing System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
endomina system
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology