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

Microsurge, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
233 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964109MICROSURGE LAPAROSCOPIC PERMACLIP CARTRIDGE WITH IMPLANTABLEMicrosurge, Inc.1996-11-27430
K960554DETACHATIP THORACOSCOPIC SCISSORSMicrosurge, Inc.1996-03-05250
K955408MICROSURGE THORACOSCOPIC INSTRUMENTSMicrosurge, Inc.1996-01-31650
K954641ENDO-LEADERMicrosurge, Inc.1995-12-28790
K954072MICROSURGE PUNCTURE CLOSE DEVICEMicrosurge, Inc.1995-10-26570
K954520MICROSURGE VERESS NEEDLEMicrosurge, Inc.1995-10-16180
K953121MICROSURGE THORACOSCOPIC ACCESS SYSTEMMicrosurge, Inc.1995-09-29860
K951230MICROSURGE BIPOLAR GRASPERSMicrosurge, Inc.1995-06-14860
K933750MICROSURGE REUSABLE FRONT END GRASP DEVICES, MODIFMicrosurge, Inc.1994-06-103300
K930355MICROSURGE SUCTION/IRRIGATION SYSTEM CANNULASMicrosurge, Inc.1993-06-081340
K925830MICROSURGE SUCTION/IRRIGATION SYSTEMMicrosurge, Inc.1993-05-171810
K924283MICROSURGE DETACHA-TIP SURGICAL INSTRUMENTSMicrosurge, Inc.1993-04-0722512
K922802MICROSURGE FRONT-END GRASPING DEVICESMicrosurge, Inc.1993-01-292330
K914175MICROSURGE LASER FIBER WITH SMA CONNECTORMicrosurge, Inc.1991-12-17900
K912332MICROSURGE LASER FIBER HOLDERMicrosurge, Inc.1991-08-21890

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