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510(k) K961424

INTRAN 500 by Utah Medical Products, Inc. — Product Code HFN

K961424 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "INTRAN 500". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code HFN (Transducer, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1996
Date Received
April 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Utah Medical Products, Inc.

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

Other clearances for product code HFN

  • K250897 — Koala Intrauterine Pressure Catheter (IPC-5000E) (May 22, 2025)
  • K974389 — KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHE (February 19, 1998)
  • K973746 — PRE-FILLED SYRINGE FOR KOALA IUP (November 24, 1997)
  • K954955 — STORC INTRAUTERINE PRESSURE CATHETER (April 17, 1996)
  • K955443 — INTRAN PLUS (February 20, 1996)
  • K920375 — DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (October 27, 1992)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)
  • K893503 — SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (June 12, 1989)

FDA data resources