510(k) · Cleared
ClearedDeclipsespect Laparoscopy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgiceye GmbH · IZD Probe, Uptake, Nuclear
Cleared on Apr 11, 2014 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 11, 2014
- Review
- 120 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All IZD devicesIZD Probe, Uptake, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IZD
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · IZD
Too few IZD 510(k)s in any year since 2007 to give a median.
Recalls per year · IZD
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZD
8in 2025
MAUDE reports naming product code IZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 2 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
dleclipseSPECT Laparoscopy is an enhancement of the dleclipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. dleclipseSPECT Laparoscopy is intended to use the said detector and generate images of the distribution of radionuclides in the human…
Read the full statement (215 words)
dleclipseSPECT Laparoscopy is an enhancement of the dleclipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. dleclipseSPECT Laparoscopy is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The dleclipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.
dleclipseSPECT Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.
dleclipseSPECT Laparoscopy is compatible currently to following nuclear uptake detectors:
Probe Probe Model Probe Handle Model Energy range of
gamine rays
ICrystal Photonics: SOCXS-OP-SZL-45 60 - 245 key
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K133781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133781: Declipsespect Laparoscopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133781
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026