FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENGAGE JAW INSERTS
K Number: K992980
·
Decision Jun 8, 2000
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
9
Review Days
279
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
- ENGAGE JAW INSERTS
- K Number
- K992980
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novare Surgical Systems, Inc.
- Date Received
- September 3, 1999
- Decision Date
- June 8, 2000
- Product Code
- DXC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXC), ordered by most recent decision date.
Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
FDA 510(k)
FDA Class 2
·Cardiovascular
Arc Adjustable Radial Cuff Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Life Saving Tourniquet
FDA 510(k)
FDA Class 2
·Cardiovascular
Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
FDA 510(k)
FDA Class 2
·Cardiovascular
Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
FDA 510(k)
FDA Class 2
·Cardiovascular
Radial Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Novare Surgical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072715 | REALHAND HIGH DEXTERITY INSTRUMENTS | Oct 16, 2007 | Substantially Equivalent |
| K071488 | REALHAND HIGH DEXTERITY (HD) INSTRUMENTS | Jun 29, 2007 | Substantially Equivalent |
| K043541 | ENDOLINK TRUE MOVEMENT SYSTEM | Mar 10, 2005 | Substantially Equivalent |
| K032589 | ENCLOSE II ANASTOMOSIS ASSIST DEVICE | Sep 5, 2003 | Substantially Equivalent |
| K023682 | ENCLOSE ANASTOMOSIS ASSIST DEVICE | Jan 16, 2003 | Substantially Equivalent |
| K010727 | FLEXLINE CLAMP | Aug 9, 2002 | Substantially Equivalent |
| K010694 | INCLUDER CLAMP | Feb 11, 2002 | Substantially Equivalent |
| K000098 | SOFTLINE SPRING CLIP | Apr 12, 2000 | Substantially Equivalent |