FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL CANNULA
K Number: K830719
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
78
Review Days
100
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
- UNIVERSAL CANNULA
- K Number
- K830719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Acufex Microsurgical, Inc.
- Date Received
- March 8, 1983
- Decision Date
- June 16, 1983
- 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 Acufex Microsurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961555 | ACUFEX TAG BIOABSORBABLE ANCHORS | Jul 10, 1996 | Substantially Equivalent |
| K961853 | PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER | Jun 21, 1996 | Substantially Equivalent |
| K954246 | ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW | Feb 15, 1996 | Substantially Equivalent for Some Indications |
| K952535 | ACUFEX ENDOBUTTON TAPE | Feb 8, 1996 | Substantially Equivalent for Some Indications |
| K953276 | ACUFEX TAG DELIVERY SYSTEM | Oct 5, 1995 | Substantially Equivalent |
| K953459 | ACUFEX TAG ANCHOR | Aug 23, 1995 | Substantially Equivalent |
| K941740 | ACUFEX ROTATOR CUFF FIXATION BUTTON | Jun 30, 1995 | Substantially Equivalent |
| K944500 | ACUFEX PATELLAR BONE BLOCK SIZER | Jun 12, 1995 | Substantially Equivalent |
| K951859 | ACUFEX ENDOBUTTON PACK | Jun 9, 1995 | Substantially Equivalent |
| K946346 | ACUFEX TAG(R) BIOABSORBABLE ANCHORS | Apr 26, 1995 | Substantially Equivalent |