VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE— 510(k) K121370

Name: FDA 510(k) clearance K121370
Creator: U.S. Food and Drug Administration
Published: 2013-08-02

Substantially Equivalent

Vectec

FDA 510(k) clearance K121370 for VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE, Substantially Equivalent on 2013-08-02. Applicant: Vectec. Device class: 2.

Clearance details

Applicant: Vectec
Product code: Code FHO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2012-05-07
Decision date: 2013-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHO

view all

K172120 — Veress Needle2017-09-14
K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT2001-04-10
K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE1997-03-27
K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM1996-08-05
K951894 — ACCESS EXPANSION SYSTEM1995-06-15

More clearances from Vectec

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.