FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
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)
K Number: K252150
·
Decision Oct 7, 2025
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
81
Review Days
90
Basic Information
- Device Name
- 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)
- K Number
- K252150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Medical Systems Corporation
- Date Received
- July 9, 2025
- Decision Date
- October 7, 2025
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Olympus Medical Systems Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D | Mar 20, 2026 | Substantially Equivalent |
| K250993 | Single Use Cytology Brush V (BC-V600P-3010) | Dec 18, 2025 | Substantially Equivalent |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Nov 25, 2025 | Substantially Equivalent |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Oct 21, 2025 | Substantially Equivalent |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) | Oct 16, 2025 | Substantially Equivalent |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Oct 10, 2025 | Substantially Equivalent |
| K250187 | Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) | Oct 7, 2025 | Substantially Equivalent |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Oct 3, 2025 | Substantially Equivalent |
| K251986 | AUXILIARY WATER TUBE MAJ-855 | Sep 26, 2025 | Substantially Equivalent |
| K251997 | Single-Use Biopsy Valve (MAJ-1555) | Sep 25, 2025 | Substantially Equivalent |