FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
K Number: K042834
·
Decision Feb 11, 2005
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
29
Review Days
121
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
- MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
- K Number
- K042834
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micromedics, Inc.
- Date Received
- October 13, 2004
- Decision Date
- February 11, 2005
- 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 Micromedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K241739 | Endoscopic Applicator, 41 cm | Jul 15, 2024 | Substantially Equivalent |
| K123847 | MALLEABLE TIP ENDOSCOPIC APPLICATOR | Jan 8, 2013 | Substantially Equivalent |
| K122526 | 360 GAS ASSISTED ENDOSCOPIC APPLICATOR | Nov 16, 2012 | Substantially Equivalent |
| K120608 | ENDOSCOPIC APPLICATOR | Mar 15, 2012 | Substantially Equivalent |
| K102563 | SINGLE CANNULA EXTENDED APPLICATOR | Mar 15, 2011 | Substantially Equivalent |
| K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | Jun 9, 2010 | Substantially Equivalent |
| K073401 | EARPOPPER, MODEL EP-2000, EP-2100, EP-3000 | Mar 14, 2008 | Substantially Equivalent |
| K061092 | BAXTER DUPLOSPRAY MIS APPLICATOR | Sep 13, 2006 | Substantially Equivalent |
| K051157 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS | Sep 1, 2005 | Substantially Equivalent |
| K050340 | MICROMEDICS SPHENOID SINUS STENT | Apr 27, 2005 | Substantially Equivalent |