510(k) K101887
- Device
- CONFIDENT SURGERY SUITE 300, MODEL CSS300
- Applicant
- SURGICEYE GMBH
- 510(k) number
- K101887
- Product code
- IZD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-22
- Date received
- 2010-07-06
- Regulation
- 892.1320
- Classification name
- Probe, Uptake, Nuclear
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MORITZ HOYER
- Address
- Friedenstrasse 18a Munich, Bavaria DE 81671 81671
FDA Registration Numbers#
- 1125612
- 1423929
- 3006051164
- 3013501110
- 9611252
- 3029904425
- 3008962177
- 2518443
- 1836161
- 8040278
- 3008492462
- 2020394
- 3001556604
- 3009518669
- 3013875526
- 1222780
- 3010027290
- 1220477
- 3018094310
- 3010273872
- 2183613
- 1219930
- 8030607
- 3008559295
- 8043980
- 3012970155
- 3003508021
- 3004636440
- 3016852448
- 3031564283
- 2031874
- 3007200016
- 2080783
- 3033043422
Source Documents#
Other 510(k) Records For Product Code IZD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133781 | DECLIPSESPECT LAPAROSCOPY | Surgiceye GmbH | 2014-04-11 |
| K123917 | DECLIPSESPECT VIEWER | Surgiceye GmbH | 2013-01-25 |
| K013751 | HANDHELD GAMMA FINDER (HGF) | Silicon Instruments Gmhb | 2002-02-06 |
| K983768 | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | 1999-07-02 |
| K982442 | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) | Care Wise Medical Products Corp. | 1998-08-25 |
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1997-06-26 |
| K961321 | GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | 1997-02-10 |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Neoprobe Corp. | 1996-09-13 |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1995-02-09 |
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | 1993-09-07 |
| K930962 | CAPTUS 2000 WEL COUNTER | Capintec Instruments, Inc. | 1993-05-18 |
| K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Capintec Instruments, Inc. | 1992-12-03 |
| K922117 | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | 1992-10-14 |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | 1992-06-10 |
| K921428 | CAPTUS 500 | Capintec Instruments, Inc. | 1992-05-28 |
Legacy Summary#
summary
FDA Review#
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