Cleared Traditional

IRRIGATION SETS

K032832 · Vital Concepts, Inc. · Orthopedic

Sep 2003

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K032832 is an FDA 510(k) clearance for the IRRIGATION SETS, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Vital Concepts, Inc. (Crofton, US). The FDA issued a Cleared decision on September 26, 2003, 15 days after receiving the submission on September 11, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K032832 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2003
Decision Date	September 26, 2003
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

Device Classification

Product Code	HRX — Arthroscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.1100
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).