FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBING SET W/ IRRIGATION & ASPIRATION VALVING
K Number: K922246
·
Decision Sep 2, 1992
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
21
Review Days
112
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
- TUBING SET W/ IRRIGATION & ASPIRATION VALVING
- K Number
- K922246
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Everest Medical Corp.
- Date Received
- May 13, 1992
- Decision Date
- September 2, 1992
- 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 Everest Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K003060 | PLASMAKINETIC GENERATOR | Oct 31, 2000 | Substantially Equivalent |
| K000496 | EVERSHEARS BIPOLAR SCISSORS | Apr 24, 2000 | Substantially Equivalent |
| K993412 | BITX PROBES | Mar 31, 2000 | Substantially Equivalent |
| K994336 | BITX PROBES | Feb 8, 2000 | Substantially Equivalent |
| K971565 | BICOAG COAGULATING FORCEPS | Mar 12, 1998 | Substantially Equivalent |
| K955001 | EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS | Dec 13, 1995 | Substantially Equivalent |
| K945975 | EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS | Dec 21, 1994 | Substantially Equivalent |
| K922509 | LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA | Oct 1, 1992 | Substantially Equivalent |
| K920089 | MONOPOLAR COAGULATING POLYPECTOMY SNARE | Mar 31, 1992 | Substantially Equivalent |
| K911787 | MONOPOLAR SPHINCTERTOME | Jul 19, 1991 | Substantially Equivalent |