Cleared Traditional

SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET

K954193 · Surgical Dynamics, Inc. · Orthopedic

Oct 1995

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K954193 is an FDA 510(k) clearance for the SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Surgical Dynamics, Inc. (Concord, US). The FDA issued a Cleared decision on October 23, 1995, 47 days after receiving the submission on September 6, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K954193 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1995
Decision Date	October 23, 1995
Days to Decision	47 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).