Electrode for Neurological Surgery 2111
FDA 510(k) K845035 · Progress Mankind Technology
510(k) numberK845035
Submission
- Device name
- Electrode for Neurological Surgery 2111
- Applicant
- Progress Mankind Technology
Hopkins, MN, US - Received
- December 27, 1984
- Decision date
- July 30, 1985
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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|---|---|---|
| K883314 | PMT 3721-1 Epidural KitCAZ · Traditional | 10/28/1988SE |
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| K871663 | PMT Traction TongsHAX · Traditional | 06/19/1987SE |
| K854157 | PMT Accupressure Infusion System 3601FRN · Traditional | 02/13/1986SE |
| K845036 | Tissue Expanders for Reconstruc-Surgery 3600LCJ · Traditional | 06/26/1985SE |
| K834047 | Pmt-Halo/Orthopedic Jacket SystemHAX · Traditional | 02/17/1984SE |
| K831329 | PMT Vaxiom Stereotactic Sys #FX001HAW · Traditional | 06/15/1983SE |
| K830530 | Temp TraceFLL · Traditional | 04/06/1983SE |
| K812744 | Levy Biotac #LX001 Biopsy Probe HolderHAW · Traditional | 12/03/1981SE |
| K810627 | Model 1301 Biotac (TM)GEA · Traditional | 04/02/1981SE |
Questions and answers
When was Electrode for Neurological Surgery 2111 cleared by the FDA?
Electrode for Neurological Surgery 2111 (K845035) received a 510(k) decision of Substantially Equivalent for Some Indications on July 30, 1985, 215 days after the submission was received.
What is the product code of K845035?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.