Atlas FDA

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

Bovie Medical · Predicate Candidate Screening

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

147 daysmedian FDA review time
260 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092149BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEBovie Medical2010-03-182450
K091440LAPAROSCOPIC RESECTION DEVICE, MODEL SR326LBovie Medical2009-10-091470
K090586BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (Bovie Medical2009-08-071560
K082568SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICEBovie Medical2008-11-17740
K082109BOVIE ICON GENERAL PURPOSE RF GENERATORBovie Medical2008-10-02690
K081431MEG LAPAROSCOPIC ELECTRODESBovie Medical2008-07-24640
K072041BOVIE IDS-400 ELECTROSURGICAL GENERATORBovie Medical2008-04-102600
K061884BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120Bovie Medical2006-09-06650

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