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510(k) K760170

INTRAUTERINE SOUND, PLASTIC DISPOSABLE by G.D. Searle and Co. — Product Code HHM

K760170 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "INTRAUTERINE SOUND, PLASTIC DISPOSABLE". The FDA issued a decision of Substantially Equivalent on July 19, 1976. The device falls under product code HHM (Sound, Uterine), a Class I device regulated under 21 CFR 884.4530. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1976
Date Received
July 6, 1976
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 G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)

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)
  • K802315 — UTERINE SOUND (January 12, 1981)
  • K781766 — UTERINE SOUND, BURNETT DISPOSABLE (December 7, 1978)

FDA data resources