Cleared Traditional

PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS

K090631 · PAJUNK GmbH Medizintechnologie · General & Plastic Surgery

Apr 2009

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K090631 is an FDA 510(k) clearance for the PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on April 16, 2009, 38 days after receiving the submission on March 9, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K090631 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2009
Decision Date	April 16, 2009
Days to Decision	38 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).