Product code HHI— Obstetrics/Gynecology

FDA has cleared 24 devices under product code HHI between 1978 and 2017, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20031 clearance
• 19981 clearance
• 19941 clearance
• 19903 clearances
• 19881 clearance
• 19873 clearances
• 19861 clearance
• 19851 clearance
• 19846 clearances
• 19831 clearance
• 19811 clearance
• 19802 clearances
• 19781 clearance

• Intl. Medical Technologies, Inc.4 clearances
• Cosmedtech, Inc.3 clearances
• Williams Specialty Products, Inc.2 clearances
• Synemed, Inc.1 clearance
• Roseburg SA1 clearance
• Personal Products Co.1 clearance
• Gyrus Acmi1 clearance
• Forma Scientific, Inc.1 clearance
• Epcom Medical Systems, Inc.1 clearance
• Engineering, Inc.1 clearance

• K171440 — Berkeley VC-10 Vacuum Curettage SystemGyrus Acmi·2017-09-29
• K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEMAcmi Corporation·2003-06-23
• K983181 — CYTOPREPCytoprep Inc. Est.·1998-11-16
• K931205 — MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTERBaxter Healthcare Corp·1994-03-15
• K904160 — CYTOSMEAR BRUSHBrooke Intl.·1990-11-02
• K900641 — CANNULA, SUCTION UTERINEWilliams Specialty Products, Inc.·1990-03-30
• K900642 — SWIVEL ADAPTERWilliams Specialty Products, Inc.·1990-03-19
• K880734 — SCENTED OR SCENTED DEODORIZED MENSTRUAL PADSPersonal Products Co.·1988-04-25
• K873552 — CANNULA AND GENERAL PURPOSE ASPIRATORCosmedtech, Inc.·1987-11-25
• K870574 — COSMEDTECH GENERAL ASPIRATORCosmedtech, Inc.·1987-03-05
• K870560 — COSMEDTECH CANNULACosmedtech, Inc.·1987-03-04
• K862476 — LS3000 CANNULA UTERINE SUCTIONEngineering, Inc.·1986-07-18
• K850312 — GYNASPYR VACUUM CURETTAGE UNITRoseburg SA·1985-02-28
• K841631 — MODEL 3014 SUCTION UNITForma Scientific, Inc.·1984-07-03
• K840381 — TAPERED CERVICAL DILATORIntl. Medical Technologies, Inc.·1984-04-30
• K840382 — VACUUM ASPIRATION CATHETERIntl. Medical Technologies, Inc.·1984-04-30
• K840383 — MENSTRUAL ASPIRATION KITIntl. Medical Technologies, Inc.·1984-04-30
• K840384 — DIAGNOSTIC DILATATION & MENSTRUAL KITIntl. Medical Technologies, Inc.·1984-04-30
• K840952 — MEDEVICE V-80 VACUUM PUMPBerkeley Medevices·1984-03-30
• K831112 — EPCOM VCU-1 VACUUM SYSTEM & CURETTEEpcom Medical Systems, Inc.·1983-06-30
• K813282 — SYNEVAC VACUUM CURETTAGE SYSTEMSSynemed, Inc.·1981-12-14
• K802360 — UTERINE VACUM ASPIRATING CURRETTEAmerican Hospital Supply Corp.·1980-10-31
• K800833 — VABRA ASPIRATORCooper Medical Devices Corp.·1980-05-14
• K780387 — VABRA ABORTION UNITCooper Laboratories·1978-04-12