Cleared Traditional

DAVOL ARTHROVENT OUTFLOW TUBING

K030307 · Davol, Inc. · Orthopedic

Feb 2003

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K030307 is an FDA 510(k) clearance for the DAVOL ARTHROVENT OUTFLOW TUBING, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on February 13, 2003, 15 days after receiving the submission on January 29, 2003. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K030307 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2003
Decision Date	February 13, 2003
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

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).