REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS— 510(k) K063788
Substantially EquivalentAscent Healthcare Solutions
FDA 510(k) clearance K063788 for REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS, Substantially Equivalent on 2007-10-15. Applicant: Ascent Healthcare Solutions. Device class: 2.
Clearance details
- Applicant
- Ascent Healthcare Solutions
- Product code
- Code NLM
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code NLM
view all- K201511 — Reprocessed Endoscopic Trocars and Sleeves
- K182828 — Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
- K172097 — Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon Universal Trocar Sleeves
- K172093 — Reprocessed Covidien Trocar
- K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
More clearances from Ascent Healthcare Solutions
view all- K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K110189 — REPROCESSED ELECTROSURGICAL INSTRUMENT
- K100909 — REPROCESSED COMPRESSION SLEEVES
- K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
Recalls naming K063788
K-number listed on FDA's recall record- Z-1834-2015 — Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
- Z-1835-2015 — Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
- Z-1836-2015 — Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063788.
Data sourced from openFDA. This site is unofficial and independent of the FDA.