FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRITON HUDSON CHUCK ATTACHMENT
K Number: K983092
·
Decision Nov 6, 1998
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
26
Applicant Total
7
Review Days
64
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
- TRITON HUDSON CHUCK ATTACHMENT
- K Number
- K983092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4370
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mednext, Inc.
- Date Received
- September 3, 1998
- Decision Date
- November 6, 1998
- Product Code
- HBB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HBB | Motor, Drill, Pneumatic | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBB), ordered by most recent decision date.
Velocity Alpha MR High Speed Surgical Drill System
FDA 510(k)
FDA Class 2
·Neurology
ELAN 4 Air Motor System
FDA 510(k)
FDA Class 2
·Neurology
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
FDA 510(k)
FDA Class 2
·Neurology
Stryker Maestro Air Motors
FDA 510(k)
FDA Class 2
·Neurology
LEGEND POWER ADAPTER MODEL: 6475000
FDA 510(k)
FDA Class 2
·Neurology
SYNTHES AIR PEN DRIVE (APD) SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Mednext, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972308 | MEDNEXT 1000 DRILL | Aug 20, 1997 | Substantially Equivalent |
| K970023 | MEDNEXT SURGICAL BUR | Feb 28, 1997 | Substantially Equivalent |
| K943108 | MEDNEXT MICRO-DRILL | Aug 17, 1994 | Substantially Equivalent |
| K935861 | MEDNEXT BUR | May 3, 1994 | Substantially Equivalent |
| K935584 | MEDNEXT BUR | Feb 22, 1994 | Substantially Equivalent |
| K926547 | MEDNEXT 1000 BONE DISSECTING SYSTEM | Jul 22, 1993 | Substantially Equivalent |