Product code HNQ— Ophthalmic

FDA has cleared 10 devices under product code HNQ between 1977 and 2003, filed by 7 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.

• 20031 clearance
• 20021 clearance
• 19881 clearance
• 19871 clearance
• 19862 clearances
• 19801 clearance
• 19791 clearance
• 19772 clearances

• Edward Weck, Inc.4 clearances
• Stephens Instruments1 clearance
• Ophtec, USA1 clearance
• Look, Inc.1 clearance
• Keeler Instruments, Inc.1 clearance
• Eye-Ko, Inc.1 clearance
• Advanced Surgical Products, Inc.1 clearance

• K030471 — OPHTEC ENCLAVATION NEEDLEOphtec, USA·2003-04-17
• K022842 — STEPHENS DISPOSABLE HOOKSStephens Instruments·2002-11-01
• K874991 — PRISMA DISPOSABLE IRRIGATING IRIS HOOKAdvanced Surgical Products, Inc.·1988-04-13
• K870440 — LOOK LENS LOOPSLook, Inc.·1987-02-20
• K864292 — DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGYEye-Ko, Inc.·1986-12-29
• K863988 — THORTON TITANIUM HOOK ANGLED RIGHTKeeler Instruments, Inc.·1986-10-31
• K801469 — BONN MICRO IRIS HOOK (NON-STERILE) #7613Edward Weck, Inc.·1980-07-28
• K791985 — HOOKS #'S 7600,7602,7603,7616Edward Weck, Inc.·1979-10-04
• K770103 — HOOK, IRIS, SHEPARD U-SHAPEDEdward Weck, Inc.·1977-01-25
• K770098 — HOOK, IRIS, HERSHMANEdward Weck, Inc.·1977-01-24