510(k) K873964
- Device
- NICOLET DISPOSABLE PRASS PROBE
- Applicant
- NICOLET BIOMEDICAL INSTRUMENTS
- 510(k) number
- K873964
- Product code
- ETN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-20
- Date received
- 1987-09-29
- Regulation
- 874.1820
- Classification name
- Stimulator, Nerve
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND T RIDDLE
- Address
- 5225-4 Verona Rd. P.O. Box 4287 Madison WI US 53711 53711
FDA Registration Numbers#
- 3003935342
- 1211566
- 3027614879
- 3043543260
- 3003851073
- 3019878714
- 3004464325
- 3010120135
- 3013480096
- 1721676
- 2031094
- 3042364673
- 3006697681
- 1319639
- 3007207906
- 1928237
- 3023852420
- 1833920
- 3004024955
- 3016678045
- 9612501
- 3007829657
- 3014479313
- 3030412764
- 1412854
- 3000270450
- 2011171
- 3007713076
- 3018094310
- 3026023106
- 8030607
- 3009144915
- 2532027
- 3011050570
- 3004893332
- 3009973336
- 3004753785
- 3010123206
- 3010709436
- 1052723
- 3031284747
- 2031093
- 3009973505
- 3007014520
- 9617544
- 1061927
- 1030489
- 3006846753
- 3024673
- 3003120897
- 2032098
- 3025603301
- 3020018
- 2030598
- 3003477135
- 1048735
- 3007156625
- 1930870
- 3014680149
- 3012102437
- 3010047454
- 3010041430
- 1045254
- 3003080184
- 3021632375
- 3006128100
- 3045522387
- 1218017
- 2134470
- 1222275
- 3010611950
- 1526534
- 3017636737
- 1052728
- 2133772
- 1824199
- 3011766844
- 1526711
- 3008102049
- 3031550429
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ETN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253536 | Evala Nerve Stimulator (EPNR002) | Epineuron Technologies, Inc. | 2026-02-27 |
| K251672 | NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) | Medtronic Xomed, Inc. | 2026-02-10 |
| K242852 | ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) | Inomed Medizintechnik GmbH | 2025-06-13 |
| K233001 | Bioscope Neuromonitor Device | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 |
| K241917 | EARP Nerve Cuff Electrode | Retropsoas Technologies, LLC | 2024-07-31 |
| K232888 | Disposable Laryngeal Electrodes | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 |
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | 2023-10-26 |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023-10-06 |
| K231580 | NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | 2023-08-30 |
| K223254 | C2 Xplore | Inomed Medizintechnik GmbH | 2023-01-27 |
| K212164 | Mapping Suction Probe | Inomed Medizintechnik GmbH | 2022-11-11 |
| K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | Medtronic Xomed, Inc. | 2022-03-21 |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical | 2021-08-26 |
| K200886 | StimSite | Allotrope Medical, Inc. | 2020-11-10 |
| K152769 | FREMAP ELECTRODE | Ad-Tech Medical Instrument Corporation | 2016-05-06 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases