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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 a medical device manufactured by Storz Medical AG. It received FDA 510(k) clearance on 2021-02-21 under approval 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. It is manufactured by Storz Medical AG. The 510(k) number is K202112.

When was Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece approved by the FDA?

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

What company makes 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 manufactured by Storz Medical AG.

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.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Storz Medical AG

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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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