Home / 510(k) Clearances / K261544

510(k) K261544

Hydro Irrigation System by Stryker Instruments — Product Code EOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2026
Date Received
May 8, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nasopharyngoscope (Flexible Or Rigid)
Device Class
Class II
Regulation Number
874.4760
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 Stryker Instruments

  • K253679 — Hydro Irrigation System (May 8, 2026)
  • K252282 — SurgiCount+ System (March 16, 2026)
  • K251971 — RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillati (September 25, 2025)
  • K250483 — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (September 9, 2025)
  • K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBl (May 15, 2025)
  • K250327 — OptaBlate Radiofrequency (RF) Generator System (April 15, 2025)
  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K243958 — Consolidated Operating Room Equipment (CORE) 2 Console (March 21, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K242834 — System 9 Sterile Battery Container (January 16, 2025)

Other clearances for product code EOB

  • K254133 — ENTity USB Videoscope System (May 14, 2026)
  • K253184 — Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endosco (March 25, 2026)
  • K252050 — Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (March 20, 2026)
  • K241731 — Outlook Surgical Versa One System (8900139) (August 11, 2025)
  • K243639 — Portare System (FA-001) (June 5, 2025)
  • K243380 — VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (March 3, 2025)
  • K234096 — MonoStereo (September 19, 2024)
  • K232435 — Rhinolaryngoscope system (April 26, 2024)
  • K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507. (August 3, 2023)
  • K222587 — PatCom Distal Chip Endoscope (July 28, 2023)