510(k) K230536
- Device
- Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
- 510(k) number
- K230536
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-14
- Date received
- 2023-02-27
- 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
Applicant Contact#
- Contact
- Du Jing
- Address
- 1/F, Bldg. 12, Innovation And Entrepreneurship Service Center No 9 Chuanqi W. Rd., Jiuhua Economic Development Xiangtan CN 411100 411100
FDA Registration Numbers#
- 3013557562
- 3023339162
- 3016045249
- 8043903
- 3014055212
- 3012322232
- 3006154292
- 9614641
- 3009420598
- 1643264
- 8010591
- 1833700
- 1221934
- 1421101
- 1045254
- 3007532396
- 3044675089
- 3013298431
- 8010047
- 3023102955
- 1526611
- 2183911
- 3015925378
- 3011050570
- 3004612223
- 3001614464
- 3011543740
- 3015552886
- 3025482817
- 3004644065
- 3003604053
- 3024021261
- 3030142846
- 9610773
- 9612074
- 3004040397
- 3012797688
- 3003418325
- 3005216736
- 1218141
- 3014615697
- 3005809810
- 3003637092
- 3006891611
- 3014334038
- 9614434
- 3015316279
- 3014342096
- 9610595
- 3017636737
- 3004638277
- 2650143
- 3008439484
- 9610877
- 1650907
- 3042172882
- 3008868758
- 2085947
- 3010202439
- 3008386005
- 9515015
- 9612501
- 3005465238
- 1057421
- 3016592765
- 3022631687
- 3008040402
- 9610617
- 3017367014
- 3033509898
- 2244478
- 3025603301
- 3009171251
- 3002808148
- 3014605202
- 3002807315
- 3010772972
- 3008114965
- 3015967359
- 9614969
Source Documents#
Other 510(k) Records For Product Code EOB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254299 | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | Karl Storz SE & CO. KG | 2026-09-15 |
| K261544 | Hydro Irrigation System | Stryker Instruments | 2026-06-17 |
| 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 |
| 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 |