510(k) K172614
- Device
- 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
- Applicant
- Caldera Medical, Inc.
- 510(k) number
- K172614
- Product code
- PWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-04
- Date received
- 2017-08-31
- Regulation
- 884.4910
- Classification name
- Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Vicki Gail
- Address
- 5171 Clareton Dr. Agoura Hills CA US 91301 91301
FDA Registration Numbers#
- 3021632375
- 3015924373
- 1828132
- 3003702646
- 1000121056
- 3005099803
- 2124215
- 3014272734
- 3003990090
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PWJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181151 | GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System | ETHICON, Inc. | 2018-08-10 |
| K173019 | GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | ETHICON, Inc. | 2018-07-06 |
| K173162 | GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide | ETHICON, Inc. | 2018-06-28 |
| K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | Boston Scientific Corporation | 2017-12-20 |
Legacy Summary#
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FDA Review#
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