Decision Date2022-03-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ReNew Disposable Scissor Tips is a medical device manufactured by Microline Surgical, Inc.. It received FDA 510(k) clearance on 2022-03-02 under approval number K213127. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ReNew Disposable Scissor Tips?
ReNew Disposable Scissor Tips is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Microline Surgical, Inc.. The 510(k) number is K213127.
When was ReNew Disposable Scissor Tips approved by the FDA?
ReNew Disposable Scissor Tips received FDA 510(k) clearance on 2022-03-02, under approval number K213127.
What company makes ReNew Disposable Scissor Tips?
ReNew Disposable Scissor Tips is manufactured by Microline Surgical, Inc..
What is the FDA product code for ReNew Disposable Scissor Tips?
The FDA product code for ReNew Disposable Scissor Tips is GEI.
Other Devices by Microline Surgical, Inc.
K160706ReNew V Handpiece Laparoscopic Instruments
K152745ReNew Sterilization Trays(Catalog #3708 and #3709)
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
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: GEI)
Official Source
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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.