Cleared Traditional

KSEA SPINOSCOPE

K023187 · Karl Storz Endoscopy · Orthopedic

Dec 2002

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K023187 is an FDA 510(k) clearance for the KSEA SPINOSCOPE, a Arthroscope (Class II — Special Controls, product code HRX), submitted by Karl Storz Endoscopy (Culver City, US). The FDA issued a Cleared decision on December 2, 2002, 69 days after receiving the submission on September 24, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.1100.

Submission Details

510(k) Number	K023187 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2002
Decision Date	December 02, 2002
Days to Decision	69 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).