Cleared Traditional

K011202 - MSI BIPOLAR SHEATH
(FDA 510(k) Clearance)

K011202 · Medical Scientific, Inc. · Orthopedic

Dec 2001

Decision

256d

Days

Class 2

Risk

K011202 is an FDA 510(k) clearance for the MSI BIPOLAR SHEATH, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Medical Scientific, Inc. (Taunton, US). The FDA issued a Cleared decision on December 31, 2001, 256 days after receiving the submission on April 19, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K011202 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2001
Decision Date	December 31, 2001
Days to Decision	256 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).