510(k) K233115
- Device
- Hawkeye Control Unit with Eyas Endoscope
- Applicant
- E Surgical, LLC
- 510(k) number
- K233115
- Product code
- HRX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-06
- Date received
- 2023-09-27
- Regulation
- 888.1100
- Classification name
- Arthroscope
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Blomeyer
- Address
- 150 Isidor Ct. Suite 203 Sparks NV US 89441 89441
FDA Registration Numbers#
- 2183449
- 3030446844
- 3015225571
- 3015316279
- 3014262693
- 3006787036
- 3012818475
- 1526534
- 3010400367
- 1030489
- 3011302058
- 3004464325
- 9611503
- 3012809732
- 3008868758
- 1030451
- 3010280860
- 8010177
- 1418479
- 3043226252
- 3016727307
- 3010120148
- 2522206
- 9617070
- 3016050940
- 3004920696
- 3015453963
- 1220477
- 3004598644
- 3016842760
- 3004111573
- 3012447612
- 1123169
- 3030153385
- 3008125983
- 2648666
- 1724474
- 3005977257
- 2133810
- 8010418
- 1450662
- 3000286616
- 3005382983
- 1226424
- 3011024991
- 3011989923
- 9610612
- 3034676720
- 3014479313
- 3005820796
- 3009394448
- 3013557562
- 3009499159
- 3011163668
- 3019269298
- 3010898856
- 3017396949
- 3027242374
- 1625507
- 3008583793
- 1061927
- 3006789154
- 3011230048
- 1824199
- 3033589330
- 1424263
- 3016851379
- 1928237
- 3015173212
- 3021336182
- 3012358417
- 1834331
- 2020601
- 1720929
- 3015207155
- 3003174284
- 3014315560
- 2951215
- 1721686
- 3010692967
Source Documents#
Other 510(k) Records For Product Code HRX#
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| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | 2025-11-21 |
| K252458 | Kyphoplasty Balloon Dilatation Catheters | Shanghai Lange Medtech Co., Ltd. | 2025-11-03 |
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025-10-15 |
| K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025-09-29 |
| K243774 | ELID (Endoscopic Less Invasive Decompression) System | Lesspine Innovations | 2025-08-27 |
| K241990 | SpineSite Endoscope System | Hydrocision, Inc. | 2025-07-30 |
| K243602 | Arthrex Spine Endoscope | Arthrex, Inc. | 2025-05-16 |
| K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024-12-11 |