FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
K Number: K152619
·
Decision Apr 29, 2016
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
16
Review Days
228
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
- Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
- K Number
- K152619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prosurg, Inc.
- Date Received
- September 14, 2015
- Decision Date
- April 29, 2016
- 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 Prosurg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula | Jul 11, 2016 | Substantially Equivalent |
| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) | May 19, 2016 | Substantially Equivalent |
| K120766 | ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) | Sep 11, 2012 | Substantially Equivalent |
| K072528 | ADJUSTABLE BONE PLATES BIOABSORBABLE, SELF COMPRESSION BONE FIXATION SYSTEM & ACCESSORIES | Dec 28, 2007 | Substantially Equivalent |
| K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | Aug 15, 2007 | Substantially Equivalent |
| K070737 | XSORB BIOABSORBABLE CRANIOFACIAL BONE FIXATION SYSTEM & ACCESSORIES | Jul 25, 2007 | Substantially Equivalent |
| K070846 | MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM | Jul 2, 2007 | Substantially Equivalent |
| K060326 | LASERTX - DIODE LASER & DELIVERY SYSTEM | Apr 5, 2006 | Substantially Equivalent |
| K050488 | TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES | Apr 1, 2005 | Substantially Equivalent |
| K042780 | NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM | Feb 3, 2005 | Substantially Equivalent |