510(k) K172156
- Device
- PENTAX Medical EPK-3000 Video Imaging System
- Applicant
- Pentax Medical
- 510(k) number
- K172156
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-05
- Date received
- 2017-07-18
- 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
- William Goeller
- Address
- 3 Paragon Dr., Montvale NJ US 07645 07645
FDA Registration Numbers#
- 9710058
- 3008837339
- 1221934
- 9610595
- 9515015
- 3001592626
- 9611680
- 3023102955
- 3025603301
- 3005465238
- 1928237
- 3011416394
- 1037007
- 9614434
- 3005382983
- 3010220595
- 3008114965
- 3011050570
- 3006345872
- 3025349506
- 3008386005
- 3014342096
- 3022631687
- 3004644065
- 3003637092
- 1048735
- 8010591
- 1057421
- 3004612223
- 3030142846
- 3006546082
- 3004638277
- 3009134855
- 3005809810
- 2650143
- 3009039068
- 3020746799
- 3014644276
- 3018094310
- 8044091
- 3004040397
- 3012797688
- 2244478
- 3033588952
- 3016678045
- 9614641
- 3015925378
- 3006891611
- 8010573
- 3015316279
- 1218141
- 9610877
- 3023339162
- 9610691
- 1643264
- 3002808148
- 3001614464
- 8043903
- 3003604053
- 3045010519
- 2027009
- 3007532396
- 1045254
- 3036756245
- 2242464
- 9610773
- 3009420598
- 9612501
- 3013298431
- 9611668
- 3003790304
- 3044675089
- 3033509898
- 2648666
- 1221826
- 3008439484
- 3017636737
- 3015552886
- 3003782610
- 3014605202
Source Documents#
Other 510(k) Records For Product Code EOB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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