Cleared Special

Benesta Tissue Removal Device

K233500 · Caldera Medical, Inc. · Obstetrics & Gynecology
Nov 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K233500 is an FDA 510(k) clearance for the Benesta Tissue Removal Device, a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Caldera Medical, Inc. (Westlake Village, US). The FDA issued a Cleared decision on November 30, 2023, 30 days after receiving the submission on October 31, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number K233500 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2023
Decision Date November 30, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
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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