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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 a medical device manufactured by Microline Surgical, Inc.. It received FDA 510(k) clearance on 2016-05-12 under approval 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. It is manufactured by Microline Surgical, Inc.. The 510(k) number is K152745.

When was ReNew Sterilization Trays(Catalog #3708 and #3709) approved by the FDA?

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

What company makes ReNew Sterilization Trays(Catalog #3708 and #3709)?

ReNew Sterilization Trays(Catalog #3708 and #3709) is manufactured by Microline Surgical, Inc..

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.

Other Devices by Microline Surgical, Inc.

K160706ReNew V Handpiece Laparoscopic Instruments K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm K213127ReNew Disposable Scissor Tips 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)

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc. K152969ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAYConmed Corporation

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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