Atlas FDA

TRU-CABLE

FDA 510(k) clearance K063309 · decided 2007-01-12

Clearance details

K-number
K063309
Device name
TRU-CABLE
Applicant
Truphatek International, Ltd.
Decision
Substantially Equivalent
Date received
2006-11-02
Decision date
2007-01-12
Days to decision
71 days
Clearance type
Traditional
Product code
FFS
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Bonita Springs, FL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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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.