Product code HGY— Obstetrics/Gynecology

FDA has cleared 27 devices under product code HGY between 1976 and 2010, filed by 22 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.

• 20101 clearance
• 20041 clearance
• 20012 clearances
• 19972 clearances
• 19952 clearances
• 19941 clearance
• 19931 clearance
• 19901 clearance
• 19853 clearances
• 19843 clearances
• 19835 clearances
• 19822 clearances
• 19812 clearances
• 19761 clearance

• Medela, Inc.3 clearances
• Hollister, Inc.2 clearances
• Gerber Products Co.2 clearances
• American Hospital Supply Corp.2 clearances
• White River (Tm)1 clearance
• White River Concepts1 clearance
• The First Years, Inc.1 clearance
• Terayco Intl., Ltd.1 clearance
• Philips Electronics UK Limited1 clearance
• Monterey Laboratories, Inc.1 clearance

• K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK Limited·2010-11-05
• K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.·2004-04-05
• K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.·2001-12-20
• K011519 — AMEDA HYGIENIKITHollister, Inc.·2001-08-15
• K971231 — WHITE RIVER MINI MANUAL BREAST PUMPWhite River Concepts·1997-05-19
• K962828 — EVERT-ITGenesis Industries, Inc.·1997-02-10
• K952034 — MEDELA'S FOOT PUMPMedela, Inc.·1995-09-12
• K952035 — NIPLETTEAvent America, Inc.·1995-07-28
• K925738 — WHITE RIVER MANUAL BREAST PUMPWhite River (Tm)·1994-05-04
• K912355 — MOTHERS TOUCH ONE HAND BREAST PUMPHollister, Inc.·1993-12-10
• K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMPGerber Products Co.·1990-09-26
• K844297 — SUPPLEMENTAL FEEDING SYSTEMMedela, Inc.·1985-02-25
• K850242 — CRYSTAL MANUAL BREAST PUMPCrystal Medical Products, Inc.·1985-02-25
• K843544 — THE BIBICURE SYS BREAST TONERLes Entreprises Bibi, Inc.·1985-01-25
• K840874 — RODY BREAST PUMPKean-Rody Manufacturer·1984-07-23
• K840325 — INFA COMPLETE BREAST PUMP & MILK STORAGMonterey Laboratories, Inc.·1984-03-05
• K834399 — NEW MOTHER'S WAY-BREAST PUMPHuntleigh Technology, Inc.·1984-01-17
• K833835 — GENTLE FLOW BREAST PUMPEklund & Co.·1983-11-28
• K831929 — BASIC BREAST PUMPTerayco Intl., Ltd.·1983-09-29
• K832597 — GERBER PRECISION CARE BREAST PUMPGerber Products Co.·1983-09-12
• K823840 — MEDELA NAMUAL BREAST PUMPMedela, Inc.·1983-01-24
• K823461 — AXIPUMP MANUAL BREAST PUMPD.J. Colgate Medical, Ltd.·1983-01-18
• K823591 — AMEDA HAND BREAST PUMPBurditt & Calkins-Siemens-Elema·1982-12-28
• K822403 — LACT-ASSIST BREAST PUMPLact-Assist, Inc.·1982-09-21
• K813247 — KANESON/COMFORT PLUS MANUAL BREAST PUMPMarshall Electronics, Inc.·1981-12-03
• K810100 — BREAST PUMPAmerican Hospital Supply Corp.·1981-02-12
• K760911 — BREAST CARE KITAmerican Hospital Supply Corp.·1976-11-11