510(k) K003830
- Device
- ENT ENDOSCOPES
- Applicant
- GLOBAL ENDOSCOPY, INC.
- 510(k) number
- K003830
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-09
- Date received
- 2000-12-11
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICK MIRCEA
- Address
- 914 W. Estes Ct. Schaumburg IL US 60193 60193
FDA Registration Numbers#
- 3009171251
- 2936485
- 1057421
- 2242464
- 2650143
- 3006546082
- 3025349506
- 3008114965
- 2518897
- 3012322232
- 1052728
- 3005527904
- 3008868758
- 3024021261
- 3003782610
- 3033588952
- 3006891611
- 3017636737
- 1045254
- 3003604053
- 3009039068
- 3013557562
- 8044091
- 3015925378
- 3010707607
- 8043903
- 3005809810
- 9610617
- 3014605202
- 1218141
- 9610595
- 8010591
- 1833700
- 1221934
- 8044098
- 8010047
- 3009420598
- 3002807315
- 3009134855
- 1048735
- 3008439484
- 3005216736
- 9610773
- 1057358
- 3014615697
- 1643264
- 3015316279
- 3007137643
- 3011050570
- 3008494403
- 3013497507
- 9612501
- 3045010519
- 3006154292
- 2243757
- 8010573
- 3010202439
- 9612074
- 3010220595
- 3014342096
- 3001592626
- 3011416394
- 3001614464
- 3015967359
- 9611102
- 3013247477
- 9614641
- 9611680
- 3007532396
- 2085947
- 3002808148
- 1421101
- 3014334038
- 3044675089
- 3004361445
- 3004040397
- 3015552886
- 1221826
- 3012797688
- 3010264076
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases