FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K172614
·
Decision May 4, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
4
Applicant Total
22
Review Days
246
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Basic Information
- Device Name
- 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
- K Number
- K172614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4910
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Caldera Medical, Inc.
- Date Received
- August 31, 2017
- Decision Date
- May 4, 2018
- Product Code
- PWJ
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PWJ), ordered by most recent decision date.
GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
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FDA Class 2
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Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K192811 | BenestaTM Tissue Removal Device | Oct 23, 2020 | 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 |
| 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 |