HNR — Forceps, Ophthalmic Class I

FDA Device Classification

FDA product code HNR covers "Forceps, Ophthalmic", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HNR
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
K022835stephens instrumentsSTEPHENS DISPOSABLE FORCEPSNovember 1, 2002
K895434alcon laboratoriesALCON FOLDING FORCEPSDecember 4, 1989
K891487western medical productsSOFT LENS FOLDING BLOCKAugust 15, 1989
K893199allergan medical opticsPHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTRJune 16, 1989
K885230alcon laboratoriesMCDONALD FOLDING FORCEPSMay 17, 1989
K881049microline pentaxBRADBURY INTRAOCULAR RETINAL KIT CAT #200September 12, 1988
K883197d and d surgicalIOL IMPLANTATION FORCEPSAugust 22, 1988
K880274advanced surgical productsADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPSFebruary 5, 1988
K864183techno ophthalmics intlOPHTHALMIC SURGICAL INSTRUMENTSNovember 28, 1986
K864266western medical productsOPHTHALMIC KNIFE & FORCEPSNovember 28, 1986
K864071staar surgicalFAULKNER FORCEPSNovember 13, 1986
K864003allerganPACO-FOLDER (TM) INTRAOCULAR LENS FORCEPSOctober 31, 1986
K863727medical technology developmentFIXATION INSTRUMENTSOctober 31, 1986
K863992keeler instrumentsTHORNTON TITANIUM FORCEPS (VARIOUS TYPES)October 31, 1986
K863991keeler instrumentsTHORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STANDOctober 31, 1986
K861057precision-cosmet coMANUAL OPHTHALMIC SURGICAL INSTRUMENTSApril 24, 1986
K861141coopervisionMANUAL OPHTHALMIC SURGICAL INSTRUMENTSApril 24, 1986
K860915storz instrumentSTORZ/MAZZACCO LENS FORCEPApril 15, 1986
K854869miraINTRAOCULAR FORCEPS & SCISSORSMarch 5, 1986
K852057ascon medical instrumentsASCON SURGICAL INSTRUMENTSJune 27, 1985