FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
ELECTRODE FOR NEUROLOGICAL SURGERY 2111
K Number: K845035
·
Decision Jul 30, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
31
Applicant Total
17
Review Days
215
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Basic Information
- Device Name
- ELECTRODE FOR NEUROLOGICAL SURGERY 2111
- K Number
- K845035
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1310
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Progress Mankind Technology
- Date Received
- December 27, 1984
- Decision Date
- July 30, 1985
- Product Code
- GYC
- 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 |
|---|---|---|---|
| GYC | Electrode, Cortical | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GYC), ordered by most recent decision date.
Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
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Other Clearances by Progress Mankind Technology
| K Number | Device Name | ||
|---|---|---|---|
| K883314 | PMT 3721-1 EPIDURAL KIT | Oct 28, 1988 | Substantially Equivalent |
| K881616 | PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 | Sep 9, 1988 | Substantially Equivalent |
| K871663 | PMT TRACTION TONGS | Jun 19, 1987 | Substantially Equivalent |
| K854157 | PMT ACCUPRESSURE INFUSION SYSTEM 3601 | Feb 13, 1986 | Substantially Equivalent |
| K845036 | TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 | Jun 26, 1985 | Substantially Equivalent |
| K834047 | PMT-HALO/ORTHOPEDIC JACKET SYSTEM | Feb 17, 1984 | Substantially Equivalent |
| K831329 | PMT VAXIOM STEREOTACTIC SYS #FX001 | Jun 15, 1983 | Substantially Equivalent |
| K830530 | TEMP TRACE | Apr 6, 1983 | Substantially Equivalent |
| K812744 | LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER | Dec 3, 1981 | Substantially Equivalent |
| K810627 | MODEL 1301 BIOTAC (TM) | Apr 2, 1981 | Substantially Equivalent |