Product code HCY— Obstetrics/Gynecology

FDA has cleared 11 devices under product code HCY between 1979 and 1998, filed by 11 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.

• 19981 clearance
• 19951 clearance
• 19941 clearance
• 19901 clearance
• 19891 clearance
• 19881 clearance
• 19861 clearance
• 19851 clearance
• 19841 clearance
• 19811 clearance
• 19791 clearance

• Premier Dental Products Co.1 clearance
• Phase I Corp.1 clearance
• Nu-Gyn-Tek, Inc.1 clearance
• Luneau Laboratories1 clearance
• Kinetic Medical Products1 clearance
• Ivory Instruments Co.1 clearance
• Imagyn Medical Technologies, Inc.1 clearance
• Gynemetrics, Inc.1 clearance
• D.L. Nelson and Assoc., Inc.1 clearance
• British Marketing Ent., Ltd.1 clearance

• K980096 — OAC (OPTICAL ASPIRATING CURETTE)Imagyn Medical Technologies, Inc.·1998-05-01
• K944238 — ENDOCYTE TMD.L. Nelson and Assoc., Inc.·1995-09-15
• K935822 — PHASE I CURETTEPhase I Corp.·1994-04-28
• K901442 — BAXTER D & C TRAYBaxter Healthcare Corp·1990-07-26
• K890384 — UTERINE CURETTEKinetic Medical Products·1989-02-13
• K881794 — IVORY FINDER SETIvory Instruments Co.·1988-07-08
• K862297 — THE D & C PAD-SACNu-Gyn-Tek, Inc.·1986-07-07
• K850068 — LUNE AU CURETTESLuneau Laboratories·1985-04-08
• K841004 — SURGICAL CURETTE, VARIOUSPremier Dental Products Co.·1984-05-11
• K802313 — UTERINE CURETTEGynemetrics, Inc.·1981-01-12
• K790032 — DISPOSABLE VACUUM CURETTEBritish Marketing Ent., Ltd.·1979-02-01