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510(k) K831224

AUGROS HYSTEROMETER by Axcan Scientific Corp. — Product Code HHM

K831224 is an FDA 510(k) premarket notification submitted by Axcan Scientific Corp. for the device "AUGROS HYSTEROMETER". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. Axcan Scientific Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
April 15, 1983
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 Axcan Scientific Corp.

  • K842943 — AXCAN UTERINE SUCCION INJECTOR (September 21, 1984)
  • K831212 — ENDOSCANN (June 15, 1984)
  • K831669 — AXCAN SPERM CUP (July 12, 1983)
  • K820641 — ACCURETTE (June 22, 1982)

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)
  • 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