Cook Cervical Ripening Balloon
FDA 510(k) K131206 · Cook, Inc.
510(k) numberK131206
Submission
- Device name
- Cook Cervical Ripening Balloon
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- April 29, 2013
- Decision date
- September 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PFJ – Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Specialty
- Obstetrics/Gynecology
Mechanical dilation of the cervical canal for labor.
Other 510(k)s with product code PFJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143424 | Utah Cvx-RipePFJ · Traditional | Utah Medical Products, Inc. | 08/28/2015SE |
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Questions and answers
When was Cook Cervical Ripening Balloon cleared by the FDA?
Cook Cervical Ripening Balloon (K131206) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 151 days after the submission was received.
What is the product code of K131206?
The FDA product code is PFJ – Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor, a Class II (moderate risk) device regulated under 21 CFR 884.4260.