Cleared Traditional

Benesta Hysteroscope

K192822 · Caldera Medical, Inc. · General Hospital
Sep 2020
Decision
344d
Days
Class 2
Risk

About This 510(k) Submission

K192822 is an FDA 510(k) clearance for the Benesta Hysteroscope, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Caldera Medical, Inc. (Agoura Hills, US). The FDA issued a Cleared decision on September 9, 2020, 344 days after receiving the submission on October 1, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K192822 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2019
Decision Date September 09, 2020
Days to Decision 344 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code HIH — Hysteroscope (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1690

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