510(k) K934623
- Device
- ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
- Applicant
- ENDOMEDIX
- 510(k) number
- K934623
- Product code
- FET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-02
- Date received
- 1993-09-27
- Regulation
- 876.1500
- Classification name
- Endoscopic Video Imaging System/component, Gastroenterology-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RANDY A WILSON
- Address
- 2162 Michelson Dr. Irvine CA US 92715 92715
FDA Registration Numbers#
- 3024021261
- 2024311
- 9610612
- 2431166
- 3009057691
- 3042225166
- 3007305485
- 1000121056
- 8010047
- 3011050570
- 3013687468
- 3010202439
- 2936485
- 3018094310
- 3015895045
- 3006161756
- 3009171251
- 3016497307
- 3028058843
- 3010398867
- 9611102
- 3004040397
- 3003018722
- 3010220595
- 3033010858
- 3004837686
- 9614434
- 3010273872
- 9610773
- 3015970743
- 3008386005
- 2183570
- 3004091527
- 3003775006
- 3011802799
- 2020550
- 3002808148
- 3036978610
- 3014644276
- 8010418
- 3016762717
- 9610595
- 3015807001
- 1017294
- 2027009
- 3015612252
- 3043152784
- 3020746799
- 3004644065
- 9610691
- 3005099803
- 3021246306
- 3015515531
- 2183911
- 3038132878
- 3015531529
- 3006786907
- 1643264
- 3012843412
- 9681260
- 3009453258
- 3022106566
- 9615782
- 3007695959
- 3013247477
- 3012322232
- 3012797688
- 9612074
- 3041659934
- 9610877
- 9615393
- 3017896224
- 3010707607
- 3003637092
- 9610617
- 3003782610
- 3014342096
- 8010298
- 3013440400
- 8043903
Source Documents#
Other 510(k) Records For Product Code FET #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251734 | ProVee Video Processing Unit (PV-003) | Proverum Limited | 2025-09-24 |
| K250462 | UL UHD-Clear View 4K Camera System (UL-3Chip 4K) | Univlabs Technologies Private Limited | 2025-08-11 |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | 2025-07-01 |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025-04-11 |
| K242067 | VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA | Olympus Corporations of the Americas | 2025-04-02 |
| K243321 | Endoscopic Video Image Processor (RP-IPD-V1000F) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-02-07 |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024-10-22 |
| K241371 | VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) | Olympus Medical Systems Corporation | 2024-07-03 |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 | Olympus Medical Systems Corporation | 2023-04-26 |
| K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | 2022-06-14 |
| K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | 2022-05-13 |
| K211332 | D Camera Controller | Richard Wolf Medical Instruments Corporation | 2021-10-01 |
| K202646 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-10-29 |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | 2020-09-01 |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | 2020-07-22 |
Legacy Summary#
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FDA Review#
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