Cleared Traditional

MICROSURGICAL INSTRUMENTS

K911300 · Danek Medical, Inc. · Orthopedic

Apr 1991

Decision

11d

Days

Class 2

Risk

About This 510(k) Submission

K911300 is an FDA 510(k) clearance for the MICROSURGICAL INSTRUMENTS, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on April 5, 1991, 11 days after receiving the submission on March 25, 1991. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K911300 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 1991
Decision Date	April 05, 1991
Days to Decision	11 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).