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FDA 510(k)

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece

K-Number: K202112 · 2021-02-21

ApplicantStorz Medical AG
Decision Date2021-02-21
Product CodePZL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Storz Medical AG. It received FDA 510(k) clearance on 2021-02-21 under 510(k) number K202112. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is a medical device that received FDA 510(k) clearance on 2021-02-21. The listed applicant is Storz Medical AG. The 510(k) number is K202112.

When did Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece receive FDA 510(k) clearance?

Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece received FDA 510(k) clearance on 2021-02-21, under 510(k) number K202112.

Who is the listed applicant for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

The FDA 510(k) record lists Storz Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece?

The FDA product code for Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece is PZL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07272720PMCF Investigation of MODULITH® SLX-F2 With StorM-Track in Patients With Kidney StonesRECRUITING

Other records listing Storz Medical AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203710Storz Medical MAGNETOLITH Muscle StimulatorPMA P080028Generator, shock-wave, for pain reliefK173692D-Actor 200 Vibration Massage System

Related Devices (Code: PZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243279DOLORCLAST Focused Shock WavesE.M.S Electro Medical Systems S.AK250779CS-Pro MEDCurative Sound TherapeuticsK233937OW100SSoftwave/Trt, LLCK231710OW100SSoftwave/Trt, LLCK200926OrthoGold 100Tissue Regeneration Technologies, LLCK191961OrthoGoldTissue Regeneration Technologies

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.

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