Cleared Traditional

ULTRA Telescopes

K150633 · Olympus Winter & Ibe GmbH · General & Plastic Surgery

Apr 2015

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K150633 is an FDA 510(k) clearance for the ULTRA Telescopes, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on April 29, 2015, 49 days after receiving the submission on March 11, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K150633 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2015
Decision Date	April 29, 2015
Days to Decision	49 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GCJ — Laparoscope, General & Plastic Surgery
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
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).