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Caldera Medical Transobturator Helical Introducer, Left +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172614

by Caldera Medical, Inc.

Identifiers

510(k) Number
K172614 FDA 510(k)
FDA Product Code
PWJ FDA 510(k)
Models / Variants
Caldera Medical Transobturator Helical Introducer, Left FDA 510(k)
Caldera Medical Transobturator Helical Introducer, Right FDA 510(k)
Caldera Medical Transobturator Large Helical Introducer, Left FDA 510(k)
Caldera Medical Transobturator Large Helical Introducer, Right FDA 510(k)
Caldera Medical Transobturator Inside-Out Introducer, Left FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.4910 FDA 510(k)
Regulation Number
884.4910 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Caldera Medical Transobturator Helical Introducer, Left +4 more models by Caldera Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Caldera Medical, Inc.

Sources (1)

  • FDA 510(k) K172614 24 fields · synced Jun 18, 2026