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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Surgin Surgical Instrumentation, Inc. · Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
172 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082110DUAL SYRINGE HOLDERSurgin Surgical Instrumentation, Inc.2009-06-173240
K033236PRIZM KERATOME BLADE, MODEL MK8512M2Surgin Surgical Instrumentation, Inc.2004-03-261720
K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BDSurgin Surgical Instrumentation, Inc.2004-01-301210
K011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORISurgin Surgical Instrumentation, Inc.2001-11-062010
K994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), Surgin Surgical Instrumentation, Inc.2000-03-151100
K980849SURGIN KITSurgin Surgical Instrumentation, Inc.1998-07-091540
K954238SURGIN GENISIS HANDPIECESurgin Surgical Instrumentation, Inc.1995-12-08880
K950600VACUUM SURGE SUPRESSERSurgin Surgical Instrumentation, Inc.1995-05-10900
K942945CASSETTE SYSTEM FOR STORZSurgin Surgical Instrumentation, Inc.1994-12-051660
K942944IRRIGATION/BIPOLAR SETSurgin Surgical Instrumentation, Inc.1994-09-27970
K942897OPTHALMIC WIPESurgin Surgical Instrumentation, Inc.1994-08-05460
K942807SURGICAL LIFT SHEETSurgin Surgical Instrumentation, Inc.1994-08-02490
K943102HIGH PERFORMANCE TIPSSurgin Surgical Instrumentation, Inc.1994-07-28290
K942518CASSETTE SYSTEM FOR SITESurgin Surgical Instrumentation, Inc.1994-07-25600
K94251710-K CASSETTESurgin Surgical Instrumentation, Inc.1994-07-25600
K94251610-0 CASSETTESurgin Surgical Instrumentation, Inc.1994-07-25600
K942515PHACO KITSurgin Surgical Instrumentation, Inc.1994-07-25600
K943070REUSABLE PROBESSurgin Surgical Instrumentation, Inc.1994-07-22240
K942896CLAMPS AND CLIPSSurgin Surgical Instrumentation, Inc.1994-07-19290
K942642SURGI-WIPESurgin Surgical Instrumentation, Inc.1994-07-15420
K942641SURGIN IRRIGATION PUMPSurgin Surgical Instrumentation, Inc.1994-07-07340
K935293FLUID ASPIRATION NEEDLESurgin Surgical Instrumentation, Inc.1994-02-151040
K934173SUTURE HANDLERSurgin Surgical Instrumentation, Inc.1993-12-01970

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda