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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 the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) 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. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K192811.

When did BenestaTM Tissue Removal Device receive FDA 510(k) clearance?

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

Who is the listed applicant for BenestaTM Tissue Removal Device?

The FDA 510(k) record lists Caldera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04772131Desara ® One Single Incision Sling 522 StudyACTIVE_NOT_RECRUITING

Other records listing Caldera Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233500Benesta Tissue Removal DeviceK211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemK192822Benesta HysteroscopeK193603Benesta Medical Sterilization TrayK191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackK172614Caldera 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

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Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

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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