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

Grieshaber & Co. · Predicate Candidate Screening

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

83 daysmedian FDA review time
239 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950056THE GRIESHABER AXIAL CUTTERGrieshaber & Co.1995-05-051190
K930842THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGEGrieshaber & Co.1994-05-034400
K914588GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGEGrieshaber & Co.1992-06-112390
K914587GRIESHABER AIR/FLUID TUBING SETGrieshaber & Co.1992-01-23990
K914586GRIESHABER THREE FUNCTION MANIPULATORGrieshaber & Co.1992-01-03790
K914585GRIESHABER TWO FUNCTION MANIPULATORGrieshaber & Co.1992-01-03790
K897119GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEPGrieshaber & Co.1990-04-121070
K900714ZZIPP INSTANT BOVIE CLEANERGrieshaber & Co.1990-03-27410
K890782GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES)Grieshaber & Co.1989-06-231280
K890783GRIESHABER VISCOELASTIC INJECTION SYSTEMGrieshaber & Co.1989-05-16900
K884043GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGEGrieshaber & Co.1988-11-16510
K863444GRIESHABER GLOBAL CONTROL TUBING SETGrieshaber & Co.1986-10-31530
K864056GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANTGrieshaber & Co.1986-10-31160
K860479GREEN-LINE BIPOLAR COAGULATION UNITGrieshaber & Co.1986-05-01830
K860502G.A.S./GRIESHABER AIR SYSTEMGrieshaber & Co.1986-02-27160

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