510(k) · Cleared
ClearedConfident Surgery Suite 300, Model CSS300
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 Mar 22, 2011 as substantially equivalent to K971167 (Neoprobe Corp., 1997) and 3 other predicates after a 259-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 22, 2011
- Review
- 259 days
- Class
- Class I
- Product code
- IZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K942580 (1995). 7 ancestors in all, the oldest K922117 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK942580 Neoprobe 1000 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1995
- 3 generations backK962319 Neoprobe 1000 Gen 1C Portable Radioisotope Detector & AccessoriesNeoprobe Corp. · 1996
- 2 generations backK971167 Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesNeoprobe Corp. · 1997
- 1 generation backK013751 Handheld Gamma Finder (HGF)Silicon Instruments Gmhb · 2002
- This deviceK101887 Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942580 | Neoprobe 1000 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1995 | — |
| −3 | K962319 | Neoprobe 1000 Gen 1C Portable Radioisotope Detector & Accessories | Neoprobe Corp. | 1996 | — |
| −2 | K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and Accessories | Neoprobe Corp. | 1997 | — |
| −1 | K013751 | Handheld Gamma Finder (HGF) | Silicon Instruments Gmhb | 2002 | — |
| 0 (this device) | K101887 | Confident Surgery Suite 300, Model CSS300 | Surgiceye GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971167 | Neoprobe Model 1500 Portable Radioisotope Detector and AccessoriesSummary page 1…CFR 3 892.1320 (2010) Predicated Devices Product: Neoprobe Model 1500 Portable Radioisotope Detector and Accessories Manufacturer: Neoprobe Corporation 510(k) number: K971167 Substantial Equivalence Date: 1997/6/26 Product: Sl-Handheld Gamma Finder (HGF) Manufacturer: Silicon Instruments, GmbH 510(k) n… | 1997 |
| * | K013751 | Handheld Gamma Finder (HGF)Summary page 1…orporation 510(k) number: K971167 Substantial Equivalence Date: 1997/6/26 Product: Sl-Handheld Gamma Finder (HGF) Manufacturer: Silicon Instruments, GmbH 510(k) number: K013751 Substantial Equivalence Date: 2002/2/6 Product: VectorVision2 Manufacturer: Brainlab, AG 510(k) number: K983831 Substantial Equ… | 2002 |
| * | K983831 | VECTORVISION2Summary page 1…Manufacturer: Silicon Instruments, GmbH 510(k) number: K013751 Substantial Equivalence Date: 2002/2/6 Product: VectorVision2 Manufacturer: Brainlab, AG 510(k) number: K983831 Substantial Equivalence Date: 1999/05/19 Product: Nexstim Eximia navigated brain stimulation system Manufacturer: Nexstim, CY 5… | 1999 |
| * | K091457 | Nexstim Eximia Navigated Brain Stimulation SystemSummary page 1…AG 510(k) number: K983831 Substantial Equivalence Date: 1999/05/19 Product: Nexstim Eximia navigated brain stimulation system Manufacturer: Nexstim, CY 510(k) number: K091457 Substantial Equivalence Date: 2009/12/08 Confidential.… | 2009 |
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.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 2 other devices also cite its predicate K971167.
How does its category compare?
All IZD devicesIZD Probe, Uptake, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics.…
Read the full statement (134 words)
Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101887: Confident Surgery Suite 300, Model CSS300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101887
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026