FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
K Number: K952926
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
302
Review Days
35
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
- QUESTUS DISPOSABLE ENDOSCOPIC KNIFE
- K Number
- K952926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wrightmedicaltechnologyinc
- Date Received
- June 26, 1995
- Decision Date
- July 31, 1995
- 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 Wrightmedicaltechnologyinc
| K Number | Device Name | ||
|---|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment System | Jan 27, 2023 | Substantially Equivalent |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | Jan 5, 2022 | Substantially Equivalent |
| K212996 | Sterile PHALINX Hammertoe System | Nov 16, 2021 | Substantially Equivalent |
| K202815 | PROPHECY Preoperative Navigation Alignment System | Mar 10, 2021 | Substantially Equivalent |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | Jan 8, 2021 | Substantially Equivalent |
| K200507 | PRO-DENSE LoVisc Bone Graft Substitute | Oct 21, 2020 | Substantially Equivalent |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | Jun 8, 2020 | Substantially Equivalent |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Aug 22, 2019 | Substantially Equivalent |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) System | Aug 13, 2019 | Substantially Equivalent |
| K183620 | PROSTEP TBC Implant System | Jun 6, 2019 | Substantially Equivalent |