Product code HHM— Obstetrics/Gynecology

FDA has cleared 10 devices under product code HHM between 1976 and 2001, filed by 9 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20011 clearance
• 19941 clearance
• 19882 clearances
• 19871 clearance
• 19841 clearance
• 19831 clearance
• 19811 clearance
• 19781 clearance
• 19761 clearance

• A & A Medical, Inc.2 clearances
• Rocket of London, Ltd.1 clearance
• Intl. Medical Technologies, Inc.1 clearance
• Gynemetrics, Inc.1 clearance
• G.D. Searle and Co.1 clearance
• Cook Ob/Gyn1 clearance
• Cervilenz, Inc.1 clearance
• C.R. Bard, Inc.1 clearance
• Axcan Scientific Corp.1 clearance

• K011840 — CERVILENZ UTERINE MEASURING SOUNDCervilenz, Inc.·2001-08-10
• K935665 — INTRAUTERINE SOUNDRocket of London, Ltd.·1994-02-24
• K884684 — ROCKET INTRAUTERINE DEPTH SOUNDA & A Medical, Inc.·1988-12-20
• K883806 — ROCKET INTRAUTERINE SOUNDA & A Medical, Inc.·1988-10-31
• K870550 — TEFLON UTERINE SOUNDCook Ob/Gyn·1987-03-04
• K840380 — UTERINE SOUNDIntl. Medical Technologies, Inc.·1984-04-30
• K831224 — AUGROS HYSTEROMETERAxcan Scientific Corp.·1983-10-28
• K802315 — UTERINE SOUNDGynemetrics, Inc.·1981-01-12
• K781766 — UTERINE SOUND, BURNETT DISPOSABLEC.R. Bard, Inc.·1978-12-07
• K760170 — INTRAUTERINE SOUND, PLASTIC DISPOSABLEG.D. Searle and Co.·1976-07-19