510(k) K061622
- Device
- PS SERIES
- Applicant
- PHOTONIC OPTISCHE GERATE GESMBH & COKG
- 510(k) number
- K061622
- Product code
- FFS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-03-05
- Date received
- 2006-06-12
- Regulation
- 876.1500
- Classification name
- Image, Illumination, Fiberoptic, For Endoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- DIETER FEGER
- Address
- Seebockgasse 59 Vienna AT A-1160 A-1160
FDA Registration Numbers#
- 3004361445
- 1526611
- 1035968
- 2916714
- 1223490
- 1221826
- 3005382983
- 3010419931
- 1226011
- 1825146
- 3007589150
- 3011050570
- 1643264
- 3010202439
- 2936485
- 2020550
- 3003604053
- 1820334
- 3014342096
- 3003768921
- 3008837339
- 3002991496
- 2242464
- 1928237
Source Documents#
Other 510(k) Records For Product Code FFS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Cook Urological, Inc. | 2007-11-20 |
| K063309 | TRU-CABLE | Truphatek International, Ltd. | 2007-01-12 |
| K061025 | ACCUTECH ENDOLITE PROBE | Accutech Medical Technologies, Inc. | 2006-05-31 |
| K023633 | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | Sovis Optique | 2002-12-31 |
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | Cogent Light Technologies, Inc. | 2000-07-17 |
| K994084 | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES | Smith & Nephew, Inc. | 2000-01-20 |
| K991323 | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR | Smith & Nephew, Inc. | 1999-07-06 |
| K983714 | SOLARTEC SOURCE 270, MODEL # 90123 | Cogent Light Technologies, Inc. | 1998-12-23 |
| K982462 | FIBER OPTIC ENDOILLUMINATION PROBE | Microvision, Inc. | 1998-09-14 |
| K980636 | FIBER OPTIC ENDOILLUMINATION PROBE | Dutch Ophthalmic USA, Inc. | 1998-05-20 |
| K970217 | VISTA ILLUMINATION SYSTEM | Vista Medical Technologies, Inc. | 1997-04-02 |
| K962595 | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS | KARL STORZ Endoscopy-America, Inc. | 1996-09-04 |
| K950960 | REDDY ILLUMINATOR | Luxtec Corp. | 1995-09-08 |
| K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | Alm Surgical Equipment, Inc. | 1994-11-04 |
| K944688 | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1994-11-01 |
Legacy Summary#
summary
FDA Review#
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