Atlas FDA

PS SERIES

FDA 510(k) clearance K061622 · decided 2007-03-05

Clearance details

K-number
K061622
Device name
PS SERIES
Applicant
Photonic Optische Gerate Gesmbh & Cokg
Decision
Substantially Equivalent
Date received
2006-06-12
Decision date
2007-03-05
Days to decision
266 days
Clearance type
Traditional
Product code
FFS
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Vienna, AT
Third-party review
Yes
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (K072521)Cook Urological, Inc.2007-11-20
TRU-CABLE (K063309)Truphatek International, Ltd.2007-01-12
ACCUTECH ENDOLITE PROBE (K061025)Accutech Medical Technologies, Inc.2006-05-31
SOVIS OPTIQUE'S ENDOSCOPIC CABLE (K023633)Sovis Optique2002-12-31
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (K001698)Cogent Light Technologies, Inc.2000-07-17
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084)Smith & Nephew, Inc.2000-01-20
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (K991323)Smith & Nephew, Inc.1999-07-06
SOLARTEC SOURCE 270, MODEL # 90123 (K983714)Cogent Light Technologies, Inc.1998-12-23
FIBER OPTIC ENDOILLUMINATION PROBE (K982462)Microvision, Inc.1998-09-14
FIBER OPTIC ENDOILLUMINATION PROBE (K980636)Dutch Ophthalmic USA, Inc.1998-05-20
VISTA ILLUMINATION SYSTEM (K970217)Vista Medical Technologies, Inc.1997-04-02
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS (K962595)KARL STORZ Endoscopy-America, Inc.1996-09-04

Recalls involving this device

No recalls on record reference this clearance.