ENTREE CANNULA— 510(k) K911813

Substantially Equivalent

Core Dynamics, Inc.

FDA 510(k) clearance K911813 for ENTREE CANNULA, Substantially Equivalent on 1991-07-19. Applicant: Core Dynamics, Inc.. Device class: 1.

Clearance details

Applicant: Core Dynamics, Inc.
Product code: Code FBM
Device class: Class 1
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1991-04-23
Decision date: 1991-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FBM

K960400 — DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)1996-03-12
K932021 — ENTREE CANNULA FASCIA ANCHORS1994-01-11
K900955 — GS-4000 REDUCER SLEEVE, 11MM TO 5MM1990-04-18
K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM1990-04-18
K900962 — GS-4300 CANNULA AND TROCAR, 5.5MM1990-04-18

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.