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510(k) K131206

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

K131206 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "COOK CERVICAL RIPENING BALLOON". The FDA issued a decision of Substantially Equivalent on September 27, 2013. The device falls under product code PFJ (Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor), a Class II device regulated under 21 CFR 884.4260. Cook, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Cook, Inc.

  • K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER (January 9, 2015)
  • K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE (December 15, 2014)
  • K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET (October 9, 2014)
  • K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUT (April 18, 2014)
  • K131772 — CANTATA(R) 2.9 MICROCATHETER (February 20, 2014)
  • K131204 — ADVANCE CS CORONARY SINUS INFUSION CATHETER (January 29, 2014)
  • K133634 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET (December 23, 2013)
  • K132020 — ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER (October 25, 2013)
  • 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)

FDA data resources