HND — Spatula, Ophthalmic Class I

FDA Device Classification

FDA product code HND covers "Spatula, Ophthalmic", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 6 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HND
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
K863990keeler instrumentsTHORNTON TITANIUM SILVER SPATULAOctober 31, 1986
K810937american v. muellerANIS IRRIGATING SPATULAMay 15, 1981
K801609edward weckMADDOX LENS SPATULA CAT. #7245August 13, 1980
K801608edward weckMCCULLEY CONTINUOUS SUTURE TIGHTNERAugust 12, 1980
K791983edward weckSPATULA'S #'S 7618,7248,7240,7242,5108October 4, 1979
K761253edward weckCYCLODIALYSIS SPAT. 15MM BLADE TITANIUMDecember 16, 1976