Home / 510(k) Clearances / K251664

510(k) K251664

Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) by Olympus Medical Systems Corporation — Product Code KTI

K251664 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022)". The FDA issued a decision of Substantially Equivalent on July 29, 2025. The device falls under product code KTI (Bronchoscope Accessory), a Class II device regulated under 21 CFR 874.4680. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2025
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bronchoscope Accessory
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Olympus Medical Systems Corporation

  • K261260 — HD Camera Head OLYMPUS CH-S200-08-LB (June 24, 2026)
  • K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (March 20, 2026)
  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K252247 — Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use (October 16, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K252150 — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); (October 7, 2025)
  • K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (October 3, 2025)

Other clearances for product code KTI

  • K251478 — ClearTip TBNA Type (April 16, 2026)
  • K254040 — LungFlow Basket Catheter (March 12, 2026)
  • K251402 — LIA-1 Catheter (542-1) (December 19, 2025)
  • K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (October 8, 2025)
  • K250263 — Disposable Grasping Forceps FG-52D/FG-54D (March 31, 2025)
  • K241679 — Disposable Cytology Brush (AF series) (March 4, 2025)
  • K231818 — METIC™- Airway Balloon Catheter (November 15, 2023)
  • K230778 — EndoCore (September 25, 2023)
  • K230280 — ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (May 11, 2023)
  • K222187 — Multistage Balloon Dilatation Catheter (March 1, 2023)

FDA data resources