510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Olympus Surgical Technologies America

Southborough, MA, US

Olympus Surgical Technologies America appears in FDA device records in Southborough, MA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
13
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 13 510(k) clearances for Olympus Surgical Technologies America between 2012 and 2026. The busiest year on record is 2013, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Olympus Surgical Technologies America, by decision year
YearClearances
20121
20132
20151
20172
20181
20192
20201
20211
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)GEXSubstantially Equivalent
K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)GEXSubstantially Equivalent
K212643POWERSEAL Curved Jaw Sealer and Divider, Double ActionGEISubstantially Equivalent
K193517ViziShot 2 FLEXKTISubstantially Equivalent
K183647SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)GEXSubstantially Equivalent
K190164CleverLock Guidewire Locking Device and Biopsy CapODCSubstantially Equivalent
K181193PeriView FLEXKTISubstantially Equivalent
K171232PeriView FLEXKTISubstantially Equivalent
K163469ViziShot 2 FLEXKTISubstantially Equivalent
K143609Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation CatheterFGESubstantially Equivalent
K132181GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETEREZNSubstantially Equivalent
K123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHKNYSubstantially Equivalent
K123319GYRUS ACMI BICOAG HEMOSTASIS PROBEKNSSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain