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510(k) K170862

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope by Solace Therapeutics, Inc. — Product Code FAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2017
Date Received
March 23, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystoscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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 Solace Therapeutics, Inc.

  • K162356 — Vesair Cystoscopic Sheath (March 2, 2017)
  • K141252 — GUARDIAN URETHRAL SHEATH (June 9, 2014)
  • K131803 — GUARDIAN URETHRAL SHEATH (August 20, 2013)

Other clearances for product code FAJ

  • K253226 — UV5000W Handle (October 23, 2025)
  • K251140 — Zenflow Spring Scope (September 23, 2025)
  • K252598 — Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (September 15, 2025)
  • K250797 — UV5000 Handle (September 11, 2025)
  • K243653 — KARL STORZ HOPKINS Telescopes for Urology (August 13, 2025)
  • K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (August 8, 2025)
  • K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS- (August 1, 2025)
  • K250269 — Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Revers (June 11, 2025)
  • K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G (December 18, 2024)
  • K243196 — Uro-G HD Cystoscope (1520) (December 13, 2024)