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FDA 510(k)

ReNew V Handpiece Laparoscopic Instruments

K-Number: K160706 · 2016-10-19

ApplicantMicroline Surgical, Inc.
Decision Date2016-10-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ReNew V Handpiece Laparoscopic Instruments is a medical device manufactured by Microline Surgical, Inc.. It received FDA 510(k) clearance on 2016-10-19 under approval number K160706. 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 V Handpiece Laparoscopic Instruments?

ReNew V Handpiece Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2016-10-19. It is manufactured by Microline Surgical, Inc.. The 510(k) number is K160706.

When was ReNew V Handpiece Laparoscopic Instruments approved by the FDA?

ReNew V Handpiece Laparoscopic Instruments received FDA 510(k) clearance on 2016-10-19, under approval number K160706.

What company makes ReNew V Handpiece Laparoscopic Instruments?

ReNew V Handpiece Laparoscopic Instruments is manufactured by Microline Surgical, Inc..

What is the FDA product code for ReNew V Handpiece Laparoscopic Instruments?

The FDA product code for ReNew V Handpiece Laparoscopic Instruments is GEI.

Other Devices by Microline Surgical, Inc.

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 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)

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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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