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510(k) K920375

DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER by Telos Medical Corp. — Product Code HFN

K920375 is an FDA 510(k) premarket notification submitted by Telos Medical Corp. for the device "DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER". The FDA issued a decision of Substantially Equivalent on October 27, 1992. The device falls under product code HFN (Transducer, Pressure, Intrauterine), a Class II device regulated under 21 CFR 884.2700. Telos Medical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1992
Date Received
January 29, 1992
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.

  • 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)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)
  • 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)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)
  • K893503 — SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (June 12, 1989)

FDA data resources