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510(k) K011840

CERVILENZ UTERINE MEASURING SOUND by Cervilenz, Inc. — Product Code HHM

K011840 is an FDA 510(k) premarket notification submitted by Cervilenz, Inc. for the device "CERVILENZ UTERINE MEASURING SOUND". The FDA issued a decision of Substantially Equivalent on August 10, 2001. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2001
Date Received
June 12, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sound, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances for product code HHM

  • K935665 — INTRAUTERINE SOUND (February 24, 1994)
  • K884684 — ROCKET INTRAUTERINE DEPTH SOUND (December 20, 1988)
  • K883806 — ROCKET INTRAUTERINE SOUND (October 31, 1988)
  • K870550 — TEFLON UTERINE SOUND (March 4, 1987)
  • K840380 — UTERINE SOUND (April 30, 1984)
  • K831224 — AUGROS HYSTEROMETER (October 28, 1983)
  • K802315 — UTERINE SOUND (January 12, 1981)
  • K781766 — UTERINE SOUND, BURNETT DISPOSABLE (December 7, 1978)
  • K760170 — INTRAUTERINE SOUND, PLASTIC DISPOSABLE (July 19, 1976)

FDA data resources