The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for 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 .
| Device ID | K172614 |
| 510k Number | K172614 |
| 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 |
| Classification | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence |
| Applicant | Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 |
| Product Code | PWJ |
| CFR Regulation Number | 884.4910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2018-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000865 | K172614 | 000 |
| 00857492008010 | K172614 | 000 |
| 00890594000933 | K172614 | 000 |
| 00890594000940 | K172614 | 000 |
| 00890594000018 | K172614 | 000 |
| 00890594000148 | K172614 | 000 |
| 00890594000162 | K172614 | 000 |
| 00890594000179 | K172614 | 000 |
| 00890594000186 | K172614 | 000 |
| 00890594000209 | K172614 | 000 |
| 00890594000216 | K172614 | 000 |
| 00890594000223 | K172614 | 000 |
| 00890594000230 | K172614 | 000 |
| 00890594000278 | K172614 | 000 |
| 00857492008003 | K172614 | 000 |