Cleared Special

Stryker Integrated Bipolar Cord and Tubing Sets

K172367 · Stryker Instruments · General & Plastic Surgery

Aug 2017

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K172367 is an FDA 510(k) clearance for the Stryker Integrated Bipolar Cord and Tubing Sets, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on August 22, 2017, 18 days after receiving the submission on August 4, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K172367 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2017
Decision Date	August 22, 2017
Days to Decision	18 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).