510(k) K220004
- Device
- Zsquare ENT-Flex Endoscope
- Applicant
- Zsquare, Ltd.
- 510(k) number
- K220004
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-06-14
- Date received
- 2022-01-04
- Regulation
- 874.4760
- Classification name
- Nasopharyngoscope (Flexible Or Rigid)
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Asaf Shahmoon
- Address
- 43 Hasivim St. Petah Tikva IL 4959501 4959501
FDA Registration Numbers
- 3024021261
- 1526611
- 3015316279
- 2243757
- 3014605202
- 2244478
- 3008494403
- 3014334038
- 1057421
- 3005423519
- 8044091
- 3044675089
- 1833700
- 3006345872
- 3005809810
- 3005527904
- 3011416394
- 3010264076
- 3033509898
- 8010047
- 8044098
- 3011050570
- 1052728
- 3010202439
- 2936485
- 3018094310
- 1218141
- 1421101
- 8010573
- 1048735
- 3009171251
- 3008868758
- 1928237
- 3025349506
- 3016592765
- 3017367014
- 3017636737
- 3009134855
- 3006154292
- 9611102
- 3007532396
- 3004361445
- 3004040397
- 3010220595
- 3013497507
- 9614969
- 9614434
- 3003790304
- 9610773
- 1037007
- 3015552886
- 1221826
- 3004638277
- 3008386005
- 3025482817
- 2085947
- 3009039068
- 3042172882
- 1221934
- 2020550
- 3002808148
- 3014644276
- 3014055212
- 8010418
- 1045254
- 2242464
- 9610595
- 3025603301
- 1650907
- 2027009
- 3014769442
- 2518897
- 3002807315
- 3015967359
- 9515015
- 3016678045
- 3006546082
- 3003418325
- 9611668
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290019505044 | Zsquare ENT-Flex Console | ZSQUARE LTD | 2023-03-23 |
| 07290019505037 | Zsquare ENT-Flex Imaging Core | ZSQUARE LTD | 2023-03-23 |
| 07290019505013 | Zsquare ENT-Flex SINGLE-USE RHINOLARYNGOSCOPE | ZSQUARE LTD | 2023-02-07 |
Other 510(k) Records For Product Code EOB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254133 | ENTity USB Videoscope System | Optim, LLC | 2026-05-14 |
| K253184 | Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) | Zhuhai Wesee Meditech Co., Ltd. | 2026-03-25 |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Olympus Medical Systems Corporation | 2026-03-20 |
| K241731 | Outlook Surgical Versa One System (8900139) | Resnent, LLC | 2025-08-11 |
| K243639 | Portare System (FA-001) | Grumpy Innovation, Inc. | 2025-06-05 |
| K243380 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | 2025-03-03 |
| K234096 | MonoStereo | Medicaltek Co., Ltd. | 2024-09-19 |
| K232435 | Rhinolaryngoscope system | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-04-26 |
| K232015 | ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) | Atmos Medizintechnik GmbH & Co. KG | 2023-08-03 |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | 2023-07-28 |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | 2023-06-14 |
| K221660 | RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP | Olympus Medical Systems Corp. | 2022-12-28 |
| K221581 | Single-Use Flexible Rhinolaryngoscope | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | Pentax of America, Inc. | 2022-11-16 |
| K221638 | Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 | Olympus Medical Systems Corp. | 2022-09-19 |