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Surgin Surgical Instrumentation, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K082110DUAL SYRINGE HOLDERJune 17, 2009
K033236PRIZM KERATOME BLADE, MODEL MK8512M2March 26, 2004
K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDJanuary 30, 2004
K011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CBNovember 6, 2001
K994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508March 15, 2000
K980849SURGIN KITJuly 9, 1998
K954238SURGIN GENISIS HANDPIECEDecember 8, 1995
K950600VACUUM SURGE SUPRESSERMay 10, 1995
K942945CASSETTE SYSTEM FOR STORZDecember 5, 1994
K942944IRRIGATION/BIPOLAR SETSeptember 27, 1994
K942897OPTHALMIC WIPEAugust 5, 1994
K942807SURGICAL LIFT SHEETAugust 2, 1994
K943102HIGH PERFORMANCE TIPSJuly 28, 1994
K94251610-0 CASSETTEJuly 25, 1994
K94251710-K CASSETTEJuly 25, 1994
K942518CASSETTE SYSTEM FOR SITEJuly 25, 1994
K942515PHACO KITJuly 25, 1994
K943070REUSABLE PROBESJuly 22, 1994
K942896CLAMPS AND CLIPSJuly 19, 1994
K942642SURGI-WIPEJuly 15, 1994