Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CryoThin™ Surgical System and Accessories

K-Number: K231661 · 2023-11-27

ApplicantMedinux (Tianjin) Technologies Co., Ltd.
Decision Date2023-11-27
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CryoThin™ Surgical System and Accessories is a medical device manufactured by Medinux (Tianjin) Technologies Co., Ltd.. It received FDA 510(k) clearance on 2023-11-27 under approval number K231661. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CryoThin™ Surgical System and Accessories?

CryoThin™ Surgical System and Accessories is a medical device that received FDA 510(k) clearance on 2023-11-27. It is manufactured by Medinux (Tianjin) Technologies Co., Ltd.. The 510(k) number is K231661.

When was CryoThin™ Surgical System and Accessories approved by the FDA?

CryoThin™ Surgical System and Accessories received FDA 510(k) clearance on 2023-11-27, under approval number K231661.

What company makes CryoThin™ Surgical System and Accessories?

CryoThin™ Surgical System and Accessories is manufactured by Medinux (Tianjin) Technologies Co., Ltd..

What is the FDA product code for CryoThin™ Surgical System and Accessories?

The FDA product code for CryoThin™ Surgical System and Accessories is GEH.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Related Devices (Code: GEH)

K162695truFreeze SystemCSA Medical, Inc. K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd. K161480R2 Dermal Cooling SystemR2 Dermatology K161294Compound W Wart Removal System Dual PowerMedtech Products, Inc. K161615AccurettH&O Equipments, Nv/Sa K161557truFreeze SystemCSA Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑