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510(k) K973746

PRE-FILLED SYRINGE FOR KOALA IUP by Clinical Innovations, Inc. — Product Code HFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1997
Date Received
October 1, 1997
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 Clinical Innovations, Inc.

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  • K223900 — babyLance Safety Heelstick (BLM, BLN, BLP) (February 24, 2023)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K140163 — KOALA TOCO (May 29, 2014)
  • K131781 — CLEARVIEW TOTAL (May 28, 2014)
  • K110605 — ROM PLUS (November 23, 2011)
  • K061539 — GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE (September 20, 2007)
  • K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000 (September 17, 2003)

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)
  • K961424 — INTRAN 500 (July 10, 1996)
  • 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)