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FDA 510(k)

SMITH & NEPHEW INSTRUMENT TRAYS

K-Number: K092551 · 2010-09-14

ApplicantSmith & Nephew Inc., Endoscopy Div.
Decision Date2010-09-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW INSTRUMENT TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. It received FDA 510(k) clearance on 2010-09-14 under 510(k) number K092551. 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 SMITH & NEPHEW INSTRUMENT TRAYS?

SMITH & NEPHEW INSTRUMENT TRAYS is a medical device that received FDA 510(k) clearance on 2010-09-14. The listed applicant is Smith & Nephew Inc., Endoscopy Div.. The 510(k) number is K092551.

When did SMITH & NEPHEW INSTRUMENT TRAYS receive FDA 510(k) clearance?

SMITH & NEPHEW INSTRUMENT TRAYS received FDA 510(k) clearance on 2010-09-14, under 510(k) number K092551.

Who is the listed applicant for SMITH & NEPHEW INSTRUMENT TRAYS?

The FDA 510(k) record lists Smith & Nephew Inc., Endoscopy Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMITH & NEPHEW INSTRUMENT TRAYS?

The FDA product code for SMITH & NEPHEW INSTRUMENT TRAYS is KCT.

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Other records listing Smith & Nephew Inc., Endoscopy Div. 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.

K242631REGENETEN™ Bioinductive ImplantK111843ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEMK102544SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAYK100159SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHORK093943BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MMK093897SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR

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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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.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.

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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