Declipsespect Laparoscopy

FDA 510(k) K133781 · Surgiceye GmbH

Substantially Equivalent

510(k) numberK133781

Submission

Device name
Declipsespect Laparoscopy
Applicant
Surgiceye GmbH
Munich, Bavaria, DE
Received
December 12, 2013
Decision date
April 11, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZD – Probe, Uptake, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1320
Specialty
Radiology

Other 510(k)s with product code IZD

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K123917Declipsespect ViewerIZD · Special Surgiceye GmbH01/25/2013SE
K101887Confident Surgery Suite 300, Model CSS300IZD · Traditional Surgiceye GmbH03/22/2011SE
K013751Handheld Gamma Finder (HGF)IZD · Traditional Silicon Instruments Gmhb02/06/2002SE
K983768Modification to Gamma Guidance SystemIZD · Traditional Radiation Monitoring Devices, Inc.07/02/1999SE
K982442C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)IZD · Traditional Care Wise Medical Products Corp.08/25/1998SE
K971167Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesIZD · Traditional Neoprobe Corp.06/26/1997SE
K961321Gamma Guidance SystemIZD · Traditional Radiation Monitoring Devices, Inc.02/10/1997SE
K962319Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesIZD · Traditional Neoprobe Corp.09/13/1996SE
K942580Neoprobe 1000 Portable Radioisotope Detector and AccessoriesIZD · Traditional Neoprobe Corp.02/09/1995SE
K932153Thyroid Uptake System & Atomlab 950 Med. SpectromeIZD · Traditional Biodan Medical Systems, Ltd.09/07/1993SE

More from Biodan Medical Systems, Ltd.

510(k)DeviceDecision
K123917Declipsespect ViewerIZD · Special 01/25/2013SE
K101887Confident Surgery Suite 300, Model CSS300IZD · Traditional 03/22/2011SE

Questions and answers

When was Declipsespect Laparoscopy cleared by the FDA?

Declipsespect Laparoscopy (K133781) received a 510(k) decision of Substantially Equivalent on April 11, 2014, 120 days after the submission was received.

What is the product code of K133781?

The FDA product code is IZD – Probe, Uptake, Nuclear, a Class I (low risk) device regulated under 21 CFR 892.1320.