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510(k) K131206

COOK CERVICAL RIPENING BALLOON by Cook, Inc. — Product Code PFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2013
Date Received
April 29, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Device Class
Class II
Regulation Number
884.4260
Review Panel
OB
Submission Type

Mechanical dilation of the cervical canal for labor.

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  • K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GAST (October 7, 2013)
  • K132334 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET (August 16, 2013)

Other clearances for product code PFJ

  • K143424 — UTAH CVX-RIPE (August 28, 2015)