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510(k) K882224

ULTRANS DISPOSABLE INTRAUTERINE by Telos Medical Corp. — Product Code HFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1989
Date Received
May 26, 1988
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 Telos Medical Corp.

  • K920375 — DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (October 27, 1992)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K914387 — TRANSCERVICAL INTRAUTERINE KIT (December 30, 1991)
  • K905018 — LAB-SITE SAFETY NEEDLE (January 16, 1991)
  • K905017 — LAB-SITE (January 15, 1991)
  • K883832 — CATHETER, INTRAUTERINE AND INTRODUCER (December 13, 1988)

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)
  • 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)
  • K893503 — SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (June 12, 1989)