FDA 510(k)

ReNew V Handpiece Laparoscopic Instruments

Numéro K : K160706 · 2016-10-19

Date de décision2016-10-19

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

ReNew V Handpiece Laparoscopic Instruments 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 2016-10-19 under 510(k) number K160706. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K160706.

When did ReNew V Handpiece Laparoscopic Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for ReNew V Handpiece Laparoscopic Instruments?

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 V Handpiece Laparoscopic Instruments?

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

Essais cliniques associés

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Autres dossiers indiquant Microline Surgical, Inc. en tant que demandeur

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 Tips K201884ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm K152745ReNew Sterilization Trays(Catalog #3708 and #3709)K152743M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

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Source officielle

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