510(k) K203739
- Device
- ELAN 4 Electro Motor System
- Applicant
- Aesculap, Inc.
- 510(k) number
- K203739
- Product code
- HBE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-24
- Date received
- 2020-12-22
- Regulation
- 882.4310
- Classification name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Kathy Racosky
- Address
- 3773 Corporate Pkwy. Center Valley PA US 18034 18034
FDA Registration Numbers
- 3036773433
- 1450662
- 3010591625
- 2650143
- 1061124
- 3001592626
- 3004464325
- 3014252644
- 3001239363
- 3015453963
- 2183744
- 3003933619
- 3023852420
- 1834331
- 1824199
- 3015212339
- 8044015
- 9681479
- 3038472982
- 3025603301
- 3010163695
- 1045834
- 3034676720
- 2025102
- 3013557562
- 9610612
- 2246552
- 2027754
- 3015882686
- 3017521423
- 3028006458
- 1625507
- 3029300352
- 3017210488
- 3002807314
- 1045254
- 2916714
- 3007031059
- 8010177
- 3005382983
- 3003800209
- 3030733800
- 3016172274
- 9614948
- 3016438694
- 1287329
- 3009973336
- 3010097171
- 3006128100
- 3002808022
- 9680741
- 8043933
- 1649518
- 1058584
- 1030489
- 2953359
- 1526611
- 3015151147
- 3005562917
- 3005282635
- 3002807310
- 3010041499
- 1723170
- 3009417901
- 8031010
- 3009732568
- 1526534
- 1828288
- 3008812560
- 1835251
- 2133641
- 3003120897
- 1825034
- 2647346
- 2648623
- 3021632375
- 3007997036
- 3040335671
- 2134947
- 9611253
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code HBE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical OY | 2026-03-26 |
| K250815 | Hubly Drill (H100) | Hubly, Inc. | 2025-11-06 |
| K252060 | GREEN | Phasor Health, LLC | 2025-10-31 |
| K252662 | UniBur | Nakanishi, Inc. | 2025-09-19 |
| K251433 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) | Surgify Medical OY | 2025-06-04 |
| K250380 | Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) | Surgify Medical OY | 2025-03-13 |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | Stryker Instruments | 2025-03-11 |
| K232684 | Surgify Halo | Surgify Medical OY | 2023-11-29 |
| K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023-05-04 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022-11-15 |
| K213072 | 2.1 x 255mm Drill, 22mm Stop | Biomet Micofixation | 2022-08-23 |
| K213208 | Twist Drills | Biomet Microfixation | 2021-12-23 |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | Medtronic Powered Surgical Solutions | 2021-11-23 |
| K202120 | P300 Attachment | Nakanishi, Inc. | 2021-10-22 |
| K210377 | Stryker iBur hubs and cutting accessories | Stryker Corporation | 2021-06-30 |