510(k) K233500
- Device
- Benesta Tissue Removal Device
- Applicant
- Caldera Medical, Inc.
- 510(k) number
- K233500
- Product code
- HIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-30
- Date received
- 2023-10-31
- Regulation
- 884.1690
- Classification name
- Hysteroscope (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Vicki Gail
- Address
- 4360 Park Ter. Dr. Suite 140 Westlake Village CA US 91361 91361
FDA Registration Numbers
- 1222780
- 3024021261
- 1221485
- 3035710892
- 3007200016
- 9617070
- 2954783
- 1519132
- 2243757
- 1222313
- 2244478
- 3008494403
- 1216677
- 3035781529
- 3007113251
- 8010047
- 3011050570
- 3012356141
- 3011986317
- 1047843
- 3010202439
- 3002907620
- 3018094310
- 2936485
- 3004784537
- 1319639
- 3021023673
- 2245304
- 3003724334
- 3007699067
- 3042158861
- 3003990090
- 3016667340
- 1064858
- 9611102
- 1219930
- 3004361445
- 1220477
- 9614434
- 3010273872
- 1056128
- 3040391040
- 3003790304
- 9610773
- 3029929134
- 1221826
- 9611503
- 3012263546
- 3008386005
- 3025482817
- 2085947
- 3004111573
- 3015142721
- 2953359
- 1643817
- 3015972753
- 1649518
- 9681753
- 3002808148
- 2020550
- 9710457
- 3014644276
- 3007960282
- 3011011193
- 3013944123
- 8010418
- 2242464
- 9610595
- 3043226252
- 8010349
- 1650907
- 3007789561
- 3014407293
- 9515015
- 3016678045
- 3006546082
- 3010399422
- 3017616393
- 9680001
- 3030733800
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HIH
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|---|---|---|---|
| K254050 | Manual Tissue Removal Device | Suzhou AcuVu Medical Technology Co., Ltd. | 2026-05-15 |
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| K252012 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2025-07-18 |
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| K241987 | Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-08-02 |
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| K231260 | HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology Co., Ltd. | 2024-03-05 |
| K233635 | SPY Cystoscope/Hysteroscope | Stryker Endoscopy | 2024-02-12 |
| K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-12 |
| K223885 | HOPKINS Telescopes | Karl Storz Endoscopy America, Inc. | 2023-09-14 |
| K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023-08-21 |
| K223520 | UNIDRIVE SIII System | Karl Storz-Endoscopy-America, Inc. | 2023-04-27 |
| K221557 | Visera Hysterovideoscope Olympus HYF Type V | Olympus Medical Systems Corporation | 2022-09-02 |