Atlas FDA

REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS

FDA 510(k) clearance K063788 · decided 2007-10-15

Clearance details

K-number
K063788
Device name
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
Applicant
Ascent Healthcare Solutions
Decision
Substantially Equivalent
Date received
2006-12-21
Decision date
2007-10-15
Days to decision
298 days
Clearance type
Traditional
Product code
NLM
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Phoenix, AZ, US
Third-party review
No
Expedited review
No

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

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Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars (K153258)Surgical Instrument Service and Savings (Dba Medline Renewal2016-04-05
REPROCESSED CLOSURE SYSTEM (K133414)Sterilmed, Inc.2014-01-22
REPROCESSED DILATING TIP TROCARS (K132629)Stryker Sustainability Solutions2013-12-31
REPROCESSED ENDOSCOPIC TROCARS (K121240)Sterilmed, Inc.2012-06-11
REPROCESSED ENDOSCOPIC TROCARS (K111002)Sterilmed, Inc.2011-07-18
REPROCESSED TROCARS, MODEL B5LT AND CB5LT (K100080)Ascent Healthcare Solutions2010-03-19
REPROCESSED TROCARS (K070059)Ascent Healthcare Solutions2007-10-02

Recalls involving this device

RecordFirmDate
Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use recall (Z-1834-2015)Stryker Sustainability Solutions2015-06-25
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated f recall (Z-1835-2015)Stryker Sustainability Solutions2015-06-25
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use recall (Z-1836-2015)Stryker Sustainability Solutions2015-06-25