Cleared Traditional

ENDO-BEND(TM) SHAVER

K950054 · Paladin Medical, Inc. · Orthopedic

Jun 1995

Decision

174d

Days

Class 2

Risk

About This 510(k) Submission

K950054 is an FDA 510(k) clearance for the ENDO-BEND(TM) SHAVER, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on June 29, 1995, 174 days after receiving the submission on January 6, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K950054 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 1995
Decision Date	June 29, 1995
Days to Decision	174 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).