Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InstruSafe Instrument Protection System

K-Number: K210836 · 2021-11-30

ApplicantSummitt Medical, LLC
Decision Date2021-11-30
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

InstruSafe Instrument Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Summitt Medical, LLC. It received FDA 510(k) clearance on 2021-11-30 under 510(k) number K210836. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InstruSafe Instrument Protection System?

InstruSafe Instrument Protection System is a medical device that received FDA 510(k) clearance on 2021-11-30. The listed applicant is Summitt Medical, LLC. The 510(k) number is K210836.

When did InstruSafe Instrument Protection System receive FDA 510(k) clearance?

InstruSafe Instrument Protection System received FDA 510(k) clearance on 2021-11-30, under 510(k) number K210836.

Who is the listed applicant for InstruSafe Instrument Protection System?

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

What is the FDA product code for InstruSafe Instrument Protection System?

The FDA product code for InstruSafe Instrument Protection System is KCT.

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

↑