Product code HRH— Ophthalmic

FDA has cleared 12 devices under product code HRH between 1977 and 2002, filed by 10 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.

• 20021 clearance
• 19941 clearance
• 19872 clearances
• 19863 clearances
• 19851 clearance
• 19841 clearance
• 19811 clearance
• 19781 clearance
• 19771 clearance

• Precision Instruments, Inc.3 clearances
• Visitec Co.1 clearance
• Storz Instrument Co.1 clearance
• Stephens Instruments1 clearance
• Steinway Instrument Co., Inc.1 clearance
• Richmond Products, Inc.1 clearance
• Intramed Laboratories, Inc.1 clearance
• Edward Weck, Inc.1 clearance
• Deknatel, Inc.1 clearance
• Codman & Shurtleff, Inc.1 clearance

• K022843 — GAYHEART CORNEAL EXCISION DEVICEStephens Instruments·2002-11-01
• K931792 — ARTHROSCOPEIntramed Laboratories, Inc.·1994-06-13
• K873918 — HEAD & CHIN RESTSRichmond Products, Inc.·1987-10-28
• K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRONPrecision Instruments, Inc.·1987-01-20
• K862524 — DEKNATEL (R) TREPHINEDeknatel, Inc.·1986-08-11
• K861825 — CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADEStorz Instrument Co.·1986-06-09
• K860648 — BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIAPrecision Instruments, Inc.·1986-03-25
• K843646 — STEINWAY MICRO-KERATO-TREPHINESteinway Instrument Co., Inc.·1985-01-03
• K843048 — RING SUPPORTED TREPHINE FOR CORNEA TRANSPrecision Instruments, Inc.·1984-10-05
• K812723 — PEARCE CORNEAL TREPHINEVisitec Co.·1981-10-13
• K781411 — CORNEAL CUTTER AND ACCESSORIESCodman & Shurtleff, Inc.·1978-09-20
• K771866 — TROUTMAN CORNEAL PUNCHEdward Weck, Inc.·1977-11-09