DeviceClearance

Ultrasonic Bipolar Generator (USG-410) +5 more— 510(k) K252150

Substantially Equivalent

Olympus Medical Systems Corporation

FDA 510(k) clearance K252150 for Ultrasonic Bipolar Generator (USG-410) +5 more, Substantially Equivalent on 2025-10-07. Applicant: Olympus Medical Systems Corporation. Device class: 2.

Clearance details

Device name as filed
Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
Applicant
Olympus Medical Systems Corporation
Product code
Code GEI
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hachioji-Shi, JP
Download summary PDFView on FDA.gov ↗

Recent devices under product code GEI

view all

More clearances from Olympus Medical Systems Corporation

view all

Adverse events under product code GEI

product code GEI
Death
133
Injury
7,585
Malfunction
35,808
Other
44
Total
43,570

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K252150

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K252150.

Data sourced from openFDA. This site is unofficial and independent of the FDA.