FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
K Number: K251664
·
Decision Jul 29, 2025
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
32
Applicant Total
81
Review Days
60
Basic Information
- Device Name
- Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)
- K Number
- K251664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus Medical Systems Corporation
- Date Received
- May 30, 2025
- Decision Date
- July 29, 2025
- Product Code
- KTI
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| KTI | Bronchoscope Accessory | FDA class 2 | Ear, Nose, Throat |
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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 |
| K252150 | 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) | Oct 7, 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 |