FDA 510(k)

Symani Surgical System

K-Number: K251510 · 2025-09-04

Decision Date2025-09-04

Product CodeSAQ

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Symani Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Microinstruments, Inc.. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251510. The device is classified under product code SAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Symani Surgical System?

Symani Surgical System is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Medical Microinstruments, Inc.. The 510(k) number is K251510.

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

Symani Surgical System received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251510.

Who is the listed applicant for Symani Surgical System?

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

What is the FDA product code for Symani Surgical System?

The FDA product code for Symani Surgical System is SAQ.

Other records listing Medical Microinstruments, 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.

K252287Symani Surgical System K242368Symani Surgical System K250014Symani Surgical System (820-03830)

Related Devices (Code: SAQ)

K252287Symani Surgical SystemMedical Microinstruments, Inc.K242368Symani Surgical SystemMedical Microinstruments, Inc.K250014Symani Surgical System (820-03830)Medical Microinstruments, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.