510(k) K990213
- Device
- HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET
- Applicant
- GYRUS ENT L.L.C.
- 510(k) number
- K990213
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-02-02
- Date received
- 1999-01-22
- Regulation
- 874.4760
- Classification name
- Nasopharyngoscope (flexible Or Rigid)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFF COBB
- Address
- 2925 Appling Rd. Bartlett TN US 38133 38133
FDA Registration Numbers#
- 1222997
- 3025349506
- 8010591
- 3015316279
- 9610617
- 8010047
- 3015967359
- 3009134855
- 3005382983
- 3016592765
- 8010573
- 3014615697
- 1057358
- 3008868758
- 3004644065
- 3009420598
- 9612501
- 3025482817
- 9515015
- 1650907
- 3003637092
- 3020746799
- 3011543740
- 3008040402
- 8010418
- 9614969
- 3012797688
- 3010220595
- 1221934
- 3001614464
- 3010707607
- 3005527904
- 2027009
- 3003782610
- 9611680
- 9610877
- 3010772972
- 3009039068
- 3014055212
- 9610773
- 1928237
- 3004638277
- 3002807315
- 1833700
- 3011050570
- 3023339162
- 2518897
- 3012322232
- 9610691
- 3016678045
- 3030142846
- 8044098
- 8043903
- 3016045249
- 3006891611
- 1057421
- 3033509898
- 3003418325
- 3014769442
- 9610595
- 2085947
- 3013497507
- 3005465238
- 1526611
- 3004040397
- 3013557562
- 3008439484
- 3017636737
- 3022631687
- 9611668
- 3010202439
- 3007137643
- 3006345872
- 1037007
- 9614641
- 3008386005
- 3014644276
- 3008114965
- 3005423519
Source Documents#
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 |
Legacy Summary#
summary
FDA Review#
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