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510(k) K802315

UTERINE SOUND by Gynemetrics, Inc. — Product Code HHM

K802315 is an FDA 510(k) premarket notification submitted by Gynemetrics, Inc. for the device "UTERINE SOUND". The FDA issued a decision of Substantially Equivalent on January 12, 1981. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. Gynemetrics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1981
Date Received
September 23, 1980
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 by Gynemetrics, Inc.

  • K811568 — CERVICAL DILATOR (July 16, 1981)
  • K803210 — MENSTRUAL ASPIRATION KITS (January 28, 1981)
  • K802313 — UTERINE CURETTE (January 12, 1981)

Other clearances for product code HHM

  • K011840 — CERVILENZ UTERINE MEASURING SOUND (August 10, 2001)
  • 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)
  • K781766 — UTERINE SOUND, BURNETT DISPOSABLE (December 7, 1978)
  • K760170 — INTRAUTERINE SOUND, PLASTIC DISPOSABLE (July 19, 1976)

FDA data resources