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FDA 510(k)

ReNew Sterilization Trays(Catalog #3708 and #3709)

K-Number: K152745 · 2016-05-12

ApplicantMicroline Surgical, Inc.
Decision Date2016-05-12
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ReNew Sterilization Trays(Catalog #3708 and #3709) is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K152745. 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 ReNew Sterilization Trays(Catalog #3708 and #3709)?

ReNew Sterilization Trays(Catalog #3708 and #3709) is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K152745.

When did ReNew Sterilization Trays(Catalog #3708 and #3709) receive FDA 510(k) clearance?

ReNew Sterilization Trays(Catalog #3708 and #3709) received FDA 510(k) clearance on 2016-05-12, under 510(k) number K152745.

Who is the listed applicant for ReNew Sterilization Trays(Catalog #3708 and #3709)?

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

What is the FDA product code for ReNew Sterilization Trays(Catalog #3708 and #3709)?

The FDA product code for ReNew Sterilization Trays(Catalog #3708 and #3709) is KCT.

Related Clinical Trials

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.

NCT05363813Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic SurgeryCOMPLETED

Other records listing Microline Surgical, 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.

K234147ReNew XR Handpiece, 25cm, with Reference Markings (3943M); ReNew XR Handpiece, 34cm, with Reference Markings (3941M); ReNew XR Handpiece, 42cm, with Reference Markings (3942M); ReNew XR Handpiece, Ratcheted, 25cm, with Reference Markings (3946M); ReNew XR Handpiece, Ratcheted, 34cm, with Reference Markings (3944M); ReNew XR Handpiece, Ratcheted, 42cm, with Reference Markings (3945M)K213127ReNew Disposable Scissor TipsK201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cmK160706ReNew V Handpiece Laparoscopic InstrumentsK152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

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.

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