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

General Surgical Innovations · Predicate Candidate Screening

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

154 daysmedian FDA review time
222 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983318FIXATION SYSTEMGeneral Surgical Innovations1999-03-011610
K973046SPACEMAKER SURGICAL BALLOON DISSECTOR, SPACEMAKER II SURGICAGeneral Surgical Innovations1998-01-161540
K972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERGeneral Surgical Innovations1997-11-141620
K970201GSI CANNULA WITH INTRODUCERGeneral Surgical Innovations1997-04-21900
K962702SPACEMAKER SERIAL SURGICAL BALLOON DISSECTOR, WITH CANNULA, General Surgical Innovations1997-02-192220
K961356MAMMARY SIZERGeneral Surgical Innovations1996-09-231680
K952278THE REUSABLE SPACEMAKER SURGICAL BALLOON DISSECTOR & CANNULAGeneral Surgical Innovations1995-08-07840
K951878SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT AGeneral Surgical Innovations1995-06-29840
K944418THE SPACEMAKER AND THE SPACEMAKER IIGeneral Surgical Innovations1994-11-01540
K944536GSI KNOTMAKERGeneral Surgical Innovations1994-10-05200
K943671GSI CANNULA REDUCER ACCESSORYGeneral Surgical Innovations1994-08-09140
K941249SPECIMEN REMOVAL DEVICEGeneral Surgical Innovations1994-07-071140
K931425SURGICAL PATCH SPREADERGeneral Surgical Innovations1994-02-223370
K926010SURGICAL DISSECTOR WITH CANNULAGeneral Surgical Innovations1993-06-252100

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