FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BenestaTM Tissue Removal Device
K Number: K192811
·
Decision Oct 23, 2020
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
170
Applicant Total
22
Review Days
389
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Basic Information
- Device Name
- BenestaTM Tissue Removal Device
- K Number
- K192811
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Caldera Medical, Inc.
- Date Received
- September 30, 2019
- Decision Date
- October 23, 2020
- Product Code
- HIH
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by Caldera Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233500 | Benesta Tissue Removal Device | Nov 30, 2023 | Substantially Equivalent |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System | Nov 10, 2021 | Substantially Equivalent |
| K192822 | Benesta Hysteroscope | Sep 9, 2020 | Substantially Equivalent |
| K193603 | Benesta Medical Sterilization Tray | Jul 20, 2020 | Substantially Equivalent |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack | Feb 7, 2020 | Substantially Equivalent |
| K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left | May 4, 2018 | Substantially Equivalent |
| K162201 | Desara TV, Desara Blue TV | Jan 11, 2017 | Substantially Equivalent |
| K150016 | Vertessa Lite | Apr 6, 2015 | Substantially Equivalent |
| K150023 | Vertessa Lite Y-Mesh | Apr 6, 2015 | Substantially Equivalent |
| K132069 | DESARA MESH, DESARA BLUE | Sep 23, 2013 | Substantially Equivalent |