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FDA 510(k)

GYNECOLOGY STERILIZATION TRAY

K-Number: K121904 · 2013-03-11

ApplicantSmith & Nephew Inc., Endoscopy Division
Decision Date2013-03-11
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GYNECOLOGY STERILIZATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Inc., Endoscopy Division. It received FDA 510(k) clearance on 2013-03-11 under 510(k) number K121904. 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 GYNECOLOGY STERILIZATION TRAY?

GYNECOLOGY STERILIZATION TRAY is a medical device that received FDA 510(k) clearance on 2013-03-11. The listed applicant is Smith & Nephew Inc., Endoscopy Division. The 510(k) number is K121904.

When did GYNECOLOGY STERILIZATION TRAY receive FDA 510(k) clearance?

GYNECOLOGY STERILIZATION TRAY received FDA 510(k) clearance on 2013-03-11, under 510(k) number K121904.

Who is the listed applicant for GYNECOLOGY STERILIZATION TRAY?

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

What is the FDA product code for GYNECOLOGY STERILIZATION TRAY?

The FDA product code for GYNECOLOGY STERILIZATION TRAY is KCT.

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

K102982ENDOBUTTON DIRECTK082215OSTEORAPTOR SUTURE ANCHORK081098ENDOBUTTON CONTINUOUS LOOP (CL)K072785TWINFIX FT PKK071586BIORAPTOR 2.3 PK SUTURE ANCHORK070908SMITH & NEPHEW KINSA RC 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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