Atlas FDA

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

Olympus Surgical Technologies America · Predicate Candidate Screening

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

98 daysmedian FDA review time
147 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIOlympus Surgical Technologies America2026-07-241010
K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIOlympus Surgical Technologies America2024-08-23297
K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionOlympus Surgical Technologies America2021-09-27386
K193517ViziShot 2 FLEXOlympus Surgical Technologies America2020-03-18901
K183647SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVOlympus Surgical Technologies America2019-08-092263
K190164CleverLock Guidewire Locking Device and Biopsy CapOlympus Surgical Technologies America2019-04-04630
K181193PeriView FLEXOlympus Surgical Technologies America2018-07-03600
K171232PeriView FLEXOlympus Surgical Technologies America2017-09-211470
K163469ViziShot 2 FLEXOlympus Surgical Technologies America2017-04-061150
K143609Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterOlympus Surgical Technologies America2015-03-27980
K132181GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETEROlympus Surgical Technologies America2013-10-21980
K123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies America2013-02-041180
K123319GYRUS ACMI BICOAG HEMOSTASIS PROBEOlympus Surgical Technologies America2012-12-14491

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