
Caldera Medical, Inc.
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Benesta Hysteroscope is an FDA 510(k)-cleared medical device (K192822) manufactured by Caldera Medical, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 2020. Regulation: 8.

Ansell
SKU MSC846624

Princeton BioMeditech Corp.
SKU K014192

McKesson
SKU VM-1270030

Hollister
SKU VM-1270031