ENTREE NEEDLE— 510(k) K914426

Substantially Equivalent

Core Dynamics, Inc.

FDA 510(k) clearance K914426 for ENTREE NEEDLE, Substantially Equivalent on 1991-11-27. Applicant: Core Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Core Dynamics, Inc.
Product code: Code FHO
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-02
Decision date: 1991-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FHO

K172120 — Veress Needle2017-09-14
K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE2013-08-02
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

More clearances from Core Dynamics, Inc.

K992250 — CORE AUDIBLE TROCAR II1999-09-24
K992190 — CORE POUCH1999-09-01
K955490 — LAPAROSCOPIC KNITTER1996-01-22
K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM1995-10-20
K953409 — LAPAROSCOPIC TROCAR1995-10-16

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