510(k) K012543
- Device
- VISION SCIENCES ENDOSHEATH SYSTEM
- Applicant
- VISION-SCIENCES, INC.
- 510(k) number
- K012543
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-15
- Date received
- 2001-08-07
- 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
- PAMELA PAPINEU
- Address
- 5 Whitcomb Ave. Ayer MA US 01432 01432
FDA Registration Numbers#
- 3015967359
- 3008494403
- 3004040397
- 3005809810
- 3003637092
- 3023102955
- 9611102
- 3024021261
- 1222997
- 2242464
- 3001592626
- 3016678045
- 2243757
- 3017636737
- 3005527904
- 3004638277
- 9614434
- 3016592765
- 3009171251
- 9614641
- 3025603301
- 3012322232
- 2650143
- 3013557562
- 2936485
- 9610877
- 3014615697
- 3011050570
- 3008439484
- 2085947
- 3008386005
- 3008253300
- 3005216736
- 3006786907
- 3045010519
- 3013247477
- 1221826
- 3002808148
- 3022631687
- 1833700
- 1928237
- 1052728
- 1643264
- 3005465238
- 3025349506
- 1421101
- 3010707607
- 3013497507
- 3020746799
- 8010047
- 8010591
- 1650907
- 8010418
- 3008868758
- 2518897
- 3008040402
- 3014055212
- 9611680
- 3018094310
- 3015316279
- 3033588952
- 8043903
- 1526611
- 3004644065
- 3015925378
- 3006891611
- 3003782610
- 3010202439
- 3030142846
- 1057421
- 9710058
- 3036756245
- 3005382983
- 9515015
- 9612074
- 2183911
- 3007532396
- 3014769442
- 2648666
- 3008114965
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 |
| 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#
summary
FDA Review#
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