Atlas FDA

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

Surgical Innovations Plc — Predicate Candidate Screening

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

178 daysmedian FDA review time
412 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123110PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301Surgical Innovations Plc2013-01-171060
K112659SURGICAL RETRACTORSSurgical Innovations Plc2012-03-091780
K111986LOGIC LAPAROSCOPIC INSTRUMENT SYSTEMSurgical Innovations Plc2012-01-261970
K100109LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICESurgical Innovations Plc2010-07-151820
K063485LOGIC LAPAROSCOPIC SCISSORSSurgical Innovations Plc2006-12-01140
K955393NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPESurgical Innovations Plc1997-01-094120
K962193PORTLAND TROCARSSurgical Innovations Plc1996-08-28820

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