FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAIN DOC
K Number: K941342
·
Decision Oct 13, 1995
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
21
Review Days
598
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
- PAIN DOC
- K Number
- K941342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Regulatory & Marketing Services, Inc.
- Date Received
- February 22, 1994
- Decision Date
- October 13, 1995
- Product Code
- GZB
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZB), ordered by most recent decision date.
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation System
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation System
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
FDA 510(k)
FDA Class 2
·Neurology
Nalu Neurostimulation SCS system
FDA 510(k)
FDA Class 2
·Neurology
SandShark Injectable Anchor (SIA) System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Regulatory & Marketing Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944673 | MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE | Apr 10, 1996 | Substantially Equivalent |
| K954752 | PEDIATRIC EUROPHYLIC FOLEY CATHETER | Oct 30, 1995 | Substantially Equivalent |
| K941543 | DIAL MEDICAL KIT | Feb 16, 1995 | Unknown |
| K944378 | ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K944384 | ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG | Feb 15, 1995 | Substantially Equivalent |
| K944379 | ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG | Feb 15, 1995 | Substantially Equivalent |
| K945874 | EUROMEDICAL POLY TRACHEOTOMY TUBE | Dec 27, 1994 | Substantially Equivalent |
| K944383 | ORION RED URETHRAL CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944382 | ORION ALL SILICONE FOLEY CATHETER | Dec 6, 1994 | Substantially Equivalent |
| K944377 | ORION'S URINARY DRAINAGE SET | Dec 6, 1994 | Substantially Equivalent |