Atlas FDA

AD-TECH EPIDURAL PEG ELECTRODE

FDA 510(k) clearance K912760 · decided 1992-01-15

Clearance details

K-number
K912760
Device name
AD-TECH EPIDURAL PEG ELECTRODE
Applicant
Ad-Tech Medical Instrument Corp
Decision
Substantially Equivalent
Date received
1991-06-24
Decision date
1992-01-15
Days to decision
205 days
Clearance type
Traditional
Product code
GYC
Device class
2
Regulation number
882.1310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Racine, WI, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ad-Tech Medical Instrument Corp

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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) (K250094)Neuralynx, Inc.2025-04-14
Layer 7-T (K242618)Precision Neuroscience, Corp.2025-03-30
WISE Cortical Strip (WCS) (K221123)Wise S.R.L.2022-11-22
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (K211954)Spes Medica Srl2022-11-10
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (K201931)Dixi Medical2021-10-02
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (K191346)Blackrock Microsystems2020-02-14
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode (K191186)Ad-Tech Medical Instrument Corporation2020-01-25
NeuroOne Cortical Electrode (K192764)Neuroone, Inc.2019-11-26
AirRay Subdural Cortical Electrodes (K183437)Cortec GmbH2019-03-12
SD LTM STIM Cortical Stimulator (K180761)Micromed S.P.A.2018-06-18
g.Estim PRO (K173684)G.Tec Medical Engineering GmbH2018-05-04
Cervello STIM (K151354)Blackrock Neuromed2016-01-27

Recalls involving this device

No recalls on record reference this clearance.