Cleared Traditional

NUCLEOTOME E KIT

K931109 · Surgical Dynamics, Inc. · Orthopedic

Mar 1994

Decision

391d

Days

Class 2

Risk

About This 510(k) Submission

K931109 is an FDA 510(k) clearance for the NUCLEOTOME E KIT, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Surgical Dynamics, Inc. (Alameda, US). The FDA issued a Cleared decision on March 29, 1994, 391 days after receiving the submission on March 3, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K931109 FDA.gov
FDA Decision	Cleared SN
Date Received	March 03, 1993
Decision Date	March 29, 1994
Days to Decision	391 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).