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FDA 510(k)

BenestaTM Tissue Removal Device

K-Number: K192811 · 2020-10-23

ApplicantCaldera Medical, Inc.
Decision Date2020-10-23
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BenestaTM Tissue Removal Device is a medical device manufactured by Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-10-23 under approval number K192811. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BenestaTM Tissue Removal Device?

BenestaTM Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Caldera Medical, Inc.. The 510(k) number is K192811.

When was BenestaTM Tissue Removal Device approved by the FDA?

BenestaTM Tissue Removal Device received FDA 510(k) clearance on 2020-10-23, under approval number K192811.

What company makes BenestaTM Tissue Removal Device?

BenestaTM Tissue Removal Device is manufactured by Caldera Medical, Inc..

What is the FDA product code for BenestaTM Tissue Removal Device?

The FDA product code for BenestaTM Tissue Removal Device is HIH.

Related Clinical Trials

NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT05313555 The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin TERMINATED NCT07240818 Comparison of FNB to EUS-CNB for Pancreatic Lesions NOT_YET_RECRUITING NCT02030691 Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress COMPLETED NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

Other Devices by Caldera Medical, Inc.

K162201Desara TV, Desara Blue TV K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left K192822Benesta Hysteroscope K193603Benesta Medical Sterilization Tray K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System

View all 8 devices →

Related Devices (Code: HIH)

K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, 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.

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