FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METATECH ROBINSON BOLT ACCESSORY
K Number: K882552
·
Decision Sep 8, 1988
Classifications
1
FEI Numbers
63
Registration Numbers
64
Same Product Code
102
Applicant Total
13
Review Days
79
Basic Information
- Device Name
- METATECH ROBINSON BOLT ACCESSORY
- K Number
- K882552
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- METATECH CORP.
- Date Received
- June 21, 1988
- Decision Date
- September 8, 1988
- Product Code
- GWM
- 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWM), ordered by most recent decision date.
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
FDA 510(k)
FDA Class 2
·Neurology
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
FDA 510(k)
FDA Class 2
·Neurology
B4C System
FDA 510(k)
FDA Class 2
·Neurology
CereLink ICP Monitor
FDA 510(k)
FDA Class 2
·Neurology
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
FDA 510(k)
FDA Class 2
·Neurology
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by METATECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K924314 | MOBILE STANDING FRAME | Feb 12, 1993 | Substantially Equivalent |
| K915370 | COPPER VAPOR LASER SYSTEM | Feb 7, 1992 | Substantially Equivalent |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | Sep 19, 1990 | Substantially Equivalent |
| K890865 | HEXASCAN SCANNER HANDPIECE | Mar 24, 1989 | Substantially Equivalent |
| K883541 | METALASER VASCULASE | Nov 4, 1988 | Substantially Equivalent |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | Oct 27, 1988 | Substantially Equivalent |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Sep 22, 1988 | Substantially Equivalent |
| K882367 | METATECH MICROCLIP APPLICATOR | Aug 25, 1988 | Substantially Equivalent |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Jul 18, 1988 | Substantially Equivalent |
| K881447 | METATECH METAL MICROCLIP | Jun 22, 1988 | Substantially Equivalent |