FDA 510(k)

RENASYS GO

K-Number: K152163 · 2016-09-29

Decision Date2016-09-29

Product CodeOMP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RENASYS GO is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K152163. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENASYS GO?

RENASYS GO is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K152163.

When did RENASYS GO receive FDA 510(k) clearance?

RENASYS GO received FDA 510(k) clearance on 2016-09-29, under 510(k) number K152163.

Who is the listed applicant for RENASYS GO?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENASYS GO?

The FDA product code for RENASYS GO is OMP.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: OMP)

K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.

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.