CVAC Image Processor

FDA 510(k) clearance K260013 · decided 2026-03-06

Clearance details

K-number: K260013
Device name: CVAC Image Processor
Applicant: Calyxo, Inc.
Decision: Substantially Equivalent
Date received: 2026-01-05
Decision date: 2026-03-06
Days to decision: 60 days
Clearance type: Traditional
Product code: FGB
Device class: 2
Regulation number: 876.1500
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Pleasanton, CA, US
Third-party review: No
Expedited review: No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
Zamenix™ P (K253505)	Roen Surgical, Inc.	2026-08-07
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (K260516)	MacroLux Medical Technology Co., Ltd.	2026-07-20
Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (K252929)	Anhui Happiness Workshop Instruments Co., Ltd.	2026-04-09
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) (K252468)	Zhejiang Geyi Medical Instrument Co., Ltd.	2025-12-16
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (K251951)	Guangzhou Red Pine Medical Instrument Co., Ltd.	2025-12-16
Miniature Telescope for Urology (27033AA) (K253411)	Karl Storz SE & CO. KG	2025-11-18
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (K250917)	Shenzhen Sanping Image Technology Co., Ltd.	2025-10-31
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (K252806)	Shanghai AnQing Medical Instrument Co., Ltd.	2025-10-03
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (K252703)	Boston Scientific Corporation	2025-09-24
Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (K250049)	Seplou (Zhuhai) Co., Ltd.	2025-08-26
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (K243550)	Karl Storz SE & CO. KG	2025-06-06
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (K242699)	Opcom Medical, Inc.	2025-05-28

Recalls involving this device

No recalls on record reference this clearance.