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FDA 510(k)

Streamline Surgical System

K-Number: K211680 · 2021-10-08

ApplicantNew World Medical, Inc.
Decision Date2021-10-08
Product CodeMRH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Streamline Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is New World Medical, Inc.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K211680. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Streamline Surgical System?

Streamline Surgical System is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is New World Medical, Inc.. The 510(k) number is K211680.

When did Streamline Surgical System receive FDA 510(k) clearance?

Streamline Surgical System received FDA 510(k) clearance on 2021-10-08, under 510(k) number K211680.

Who is the listed applicant for Streamline Surgical System?

The FDA 510(k) record lists New World Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Streamline Surgical System?

The FDA product code for Streamline Surgical System is MRH.

Other records listing New World Medical, Inc. 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.

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Related Devices (Code: MRH)

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.

K253760OMNI Ultra Surgical System (1-110)Sight Sciences, Inc.K243503VIA360™ Surgical SystemNew World Medical, Inc.K232214OMNI Surgical SystemSight Sciences, Inc.K213173TrabEx ProMicrosurgical Technologies, Inc.K212797iPrime Viscodelivery SystemGlaukosK202678OMNI Surgical SystemSight Sciences, Inc.

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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