HNQ — Hook, Ophthalmic Class I

FDA Device Classification

FDA product code HNQ covers "Hook, Ophthalmic", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 10 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HNQ
Device Class
Class I
Regulation Number
886.4350
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K030471ophtec, usaOPHTEC ENCLAVATION NEEDLEApril 17, 2003
K022842stephens instrumentsSTEPHENS DISPOSABLE HOOKSNovember 1, 2002
K874991advanced surgical productsPRISMA DISPOSABLE IRRIGATING IRIS HOOKApril 13, 1988
K870440lookLOOK LENS LOOPSFebruary 20, 1987
K864292eye-koDISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGYDecember 29, 1986
K863988keeler instrumentsTHORTON TITANIUM HOOK ANGLED RIGHTOctober 31, 1986
K801469edward weckBONN MICRO IRIS HOOK (NON-STERILE) #7613July 28, 1980
K791985edward weckHOOKS #'S 7600,7602,7603,7616October 4, 1979
K770103edward weckHOOK, IRIS, SHEPARD U-SHAPEDJanuary 25, 1977
K770098edward weckHOOK, IRIS, HERSHMANJanuary 24, 1977