FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K Number: K172775
·
Decision Feb 12, 2018
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
64
Review Days
151
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
- MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
- K Number
- K172775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflexmedical, Inc.
- Date Received
- September 14, 2017
- Decision Date
- February 12, 2018
- 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
Other Clearances by Teleflexmedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232469 | Rüsch Latex Gold Foley Catheter | Aug 1, 2024 | Substantially Equivalent |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Jul 27, 2023 | Substantially Equivalent |
| K192324 | Sheridan Spiral-Flex Endotracheal Tubes | Dec 6, 2019 | Substantially Equivalent |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Jul 1, 2019 | Substantially Equivalent |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | May 24, 2019 | Substantially Equivalent |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | May 8, 2019 | Unknown |
| K181852 | Percuvance Percutaneous Surgical System | Oct 12, 2018 | Substantially Equivalent |
| K173280 | Neonatal ConchaSmart Breathing Circuits | Aug 2, 2018 | Substantially Equivalent |
| K161770 | Rusch Silicone Foley Catheter | May 5, 2017 | Substantially Equivalent |
| K162522 | UltraCath Continuous Nerve block Catheter | Mar 17, 2017 | Substantially Equivalent |