FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
K Number: K120012
·
Decision Sep 11, 2012
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
65
Review Days
252
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
- INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
- K Number
- K120012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integra LifeSciences Corporation
- Date Received
- January 3, 2012
- Decision Date
- September 11, 2012
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Integra LifeSciences Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Oct 8, 2025 | Substantially Equivalent |
| K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | Apr 9, 2025 | Substantially Equivalent |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2024 | Substantially Equivalent |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2023 | Substantially Equivalent |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Aug 22, 2022 | Substantially Equivalent |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 15, 2022 | Substantially Equivalent |
| K210128 | INTEGRA Wound Matrix (Macro-Channels) | Oct 8, 2021 | Substantially Equivalent |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | Jul 27, 2021 | Substantially Equivalent |
| K193346 | Codman Surgical Patties & Strips | Nov 20, 2020 | Substantially Equivalent |
| K201507 | Cadence Total Ankle System | Jun 29, 2020 | Substantially Equivalent |