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)

Benesta Hysteroscope

K-Number: K192822 · 2020-09-09

ApplicantCaldera Medical, Inc.
Decision Date2020-09-09
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Benesta Hysteroscope is a medical device manufactured by Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-09-09 under approval number K192822. 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 Benesta Hysteroscope?

Benesta Hysteroscope is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by Caldera Medical, Inc.. The 510(k) number is K192822.

When was Benesta Hysteroscope approved by the FDA?

Benesta Hysteroscope received FDA 510(k) clearance on 2020-09-09, under approval number K192822.

What company makes Benesta Hysteroscope?

Benesta Hysteroscope is manufactured by Caldera Medical, Inc..

What is the FDA product code for Benesta Hysteroscope?

The FDA product code for Benesta Hysteroscope is HIH.

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 K192811BenestaTM Tissue Removal Device 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.

↑