Home / 510(k) Clearances / K935665

510(k) K935665

INTRAUTERINE SOUND by Rocket of London, Ltd. — Product Code HHM

K935665 is an FDA 510(k) premarket notification submitted by Rocket of London, Ltd. for the device "INTRAUTERINE SOUND". The FDA issued a decision of Substantially Equivalent on February 24, 1994. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. Rocket of London, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1994
Date Received
November 26, 1993
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 Rocket of London, Ltd.

  • K943801 — URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (August 15, 1995)
  • K932385 — SUTURE REMOVING FORCEPS (August 6, 1993)

Other clearances for product code HHM

  • K011840 — CERVILENZ UTERINE MEASURING SOUND (August 10, 2001)
  • 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