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510(k) K170862

Device
Vesair 0 Degree Cystoscope, Vesair 30 Degree Long Cystoscope, Vesair 70 Degree Long Cystoscope,Vesair 30 Degree Cystoscope,Vesair 70 Degree Cystoscope
Applicant
Solace Therapeutics, Inc.
510(k) number
K170862
Product code
FAJ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-12-19
Date received
2017-03-23
Regulation
876.1500
Classification name
Cystoscope And Accessories, Flexible/rigid
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Scott Blood
Address
135 Newbury St. Farmingham MA US 01701 01701

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FAJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,Olympus Winter & Ibe GmbH2026-05-21
K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) Ulc2026-05-11
K253905PrimeSight UltraView SystemCogentix Medical, Inc.2026-04-07
K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.2026-03-27
K253226UV5000W HandleUroviu Corporation2025-10-23
K251140Zenflow Spring ScopeZenflow, Inc.2025-09-23
K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.2025-09-15
K250797UV5000 HandleUroviu Corporation2025-09-11
K243653KARL STORZ HOPKINS Telescopes for UrologyKarl Storz SE & CO. KG2025-08-13
K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.2025-08-08
K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endoAmerican Medical Endoscopy, Inc.2025-08-01
K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)Ambu A/S2025-06-11
K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)Hunan Vathin Medical Instrument Co., Ltd.2024-12-18
K243196Uro-G HD Cystoscope (1520)Uroviu Corporation2024-12-13
K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2Ambu A/S2024-10-16

Legacy Summary#

summary

FDA Review#

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