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FDA 510(k)

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm

K-Number: K201884 · 2020-10-21

ApplicantMicroline Surgical, Inc.
Decision Date2020-10-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm 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 2020-10-21 under 510(k) number K201884. 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 XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm?

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K201884.

When did ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm receive FDA 510(k) clearance?

ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm received FDA 510(k) clearance on 2020-10-21, under 510(k) number K201884.

Who is the listed applicant for ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm?

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 XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm?

The FDA product code for ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm is GEI.

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 TipsK160706ReNew V Handpiece Laparoscopic InstrumentsK152745ReNew Sterilization Trays(Catalog #3708 and #3709)K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

Related Devices (Code: GEI)

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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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.

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