Cleared Traditional

UNIVERSAL CANNULA SYSTEM

K863590 · Aspen Laboratories, Inc. · Orthopedic

Oct 1986

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K863590 is an FDA 510(k) clearance for the UNIVERSAL CANNULA SYSTEM, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on October 23, 1986, 38 days after receiving the submission on September 15, 1986. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K863590 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 1986
Decision Date	October 23, 1986
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

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).