Cleared Traditional

K901735 - ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
(FDA 510(k) Clearance)

K901735 · Micro-Aire Surgical Instruments, Inc. · Orthopedic

Jun 1990

Decision

64d

Days

Class 2

Risk

K901735 is an FDA 510(k) clearance for the ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on June 20, 1990, 64 days after receiving the submission on April 17, 1990. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K901735 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 1990
Decision Date	June 20, 1990
Days to Decision	64 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).