Atlas FDA

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

Aragon Surgical, Inc. · Predicate Candidate Screening

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

113 daysmedian FDA review time
175 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110824ARAGON SURGICAL RF SYSTEM - 5MM LAPAROSCOPIC INSTRUMENTAragon Surgical, Inc.2011-07-111100
K093075ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENTAragon Surgical, Inc.2010-01-211130
K090306ARAGON SURGICAL RF SYSTEM L2 INSTRUMENTAragon Surgical, Inc.2009-06-181320
K081312ARAGON ONESHOT SYSTEMAragon Surgical, Inc.2008-10-311750
K073452MODIFICATION TO: ARAGON SURGICAL LAPCAPAragon Surgical, Inc.2008-01-11320
K070651ARAGON SURGICAL LAPCAPAragon Surgical, Inc.2007-05-30820

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