Home / 510(k) Clearances / K171983

510(k) K171983

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory by Creo Medical, Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
June 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Creo Medical, Ltd.

  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K242983 — CROMA Electrosurgical Generator (PRD-EMR-050) (February 5, 2025)
  • K242061 — Reusable Interface Cable 1.5 m (PRD-IFC-002) (August 15, 2024)
  • K230328 — Speedboat Flush SB1 Instrument (October 31, 2023)
  • K223138 — AB1 Electrosurgical Instrument, Creo Electrosurgical System (June 26, 2023)
  • K221672 — Creo Electrosurgical System with NP1 Instrument (February 14, 2023)
  • K200298 — ABI Instrument, Creo Electrosurgical System (January 5, 2021)
  • K200003 — NP1 Instrument, Creo Electrosurgical System (October 28, 2020)
  • K192905 — Creo Electrosurgical System with HS1 Hemostasis Accessory (March 19, 2020)

Other clearances for product code KNS

  • K252388 — Vanquish Water Vapor Ablation Device (November 26, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
  • K250584 — Rezum System (June 11, 2025)
  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
  • K242192 — Disposable Sphincterotome (February 6, 2025)