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510(k) K143424

UTAH CVX-RIPE by Utah Medical Products, Inc. — Product Code PFJ

K143424 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "UTAH CVX-RIPE". The FDA issued a decision of Substantially Equivalent on August 28, 2015. 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. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2015
Date Received
December 1, 2014
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 Utah Medical Products, Inc.

  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (January 23, 2013)
  • K101535 — BT-CATH (January 11, 2011)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (July 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)
  • K961424 — INTRAN 500 (July 10, 1996)

Other clearances for product code PFJ

  • K131206 — COOK CERVICAL RIPENING BALLOON (September 27, 2013)

FDA data resources