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510(k) K932021

ENTREE CANNULA FASCIA ANCHORS by Core Dynamics, Inc. — Product Code FBM

K932021 is an FDA 510(k) premarket notification submitted by Core Dynamics, Inc. for the device "ENTREE CANNULA FASCIA ANCHORS". The FDA issued a decision of Substantially Equivalent on January 11, 1994. The device falls under product code FBM (Cannula And Trocar, Suprapubic, Non-Disposable), a Class I device regulated under 21 CFR 876.5090. Core Dynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
April 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula And Trocar, Suprapubic, Non-Disposable
Device Class
Class I
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by Core Dynamics, Inc.

  • K992250 — CORE AUDIBLE TROCAR II (September 24, 1999)
  • K992190 — CORE POUCH (September 1, 1999)
  • K955490 — LAPAROSCOPIC KNITTER (January 22, 1996)
  • K953903 — LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM (October 20, 1995)
  • K953409 — LAPAROSCOPIC TROCAR (October 16, 1995)
  • K950457 — CANNUAL AND TROCAR, SUPERPUBIC (May 5, 1995)
  • K943172 — CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR (July 28, 1994)
  • K935826 — LAPAROSCOPIC/SUCTION/IRRIGATION PROBE (May 18, 1994)
  • K932118 — ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET (March 17, 1994)
  • K932020 — ENTREE BLUNT TIP TROCAR AND ADAPTER (January 11, 1994)

Other clearances for product code FBM

  • K960400 — DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMO (March 12, 1996)
  • K911813 — ENTREE CANNULA (July 19, 1991)
  • K900963 — GS-4350 TROCAR ONLY, 5.5MM (April 18, 1990)
  • K900964 — CANNULA AND TROCAR, 11MM (April 18, 1990)
  • K900965 — GS-4550 TROCAR ONLY, 11MM (April 18, 1990)
  • K900955 — GS-4000 REDUCER SLEEVE, 11MM TO 5MM (April 18, 1990)
  • K900962 — GS-4300 CANNULA AND TROCAR, 5.5MM (April 18, 1990)
  • K900961 — GS-4100 REDUCER SLEEVE, 5MM TO 3MM (April 18, 1990)

FDA data resources