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510(k) K932118

ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET by Core Dynamics, Inc. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1994
Date Received
May 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
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)
  • K932021 — ENTREE CANNULA FASCIA ANCHORS (January 11, 1994)
  • K932020 — ENTREE BLUNT TIP TROCAR AND ADAPTER (January 11, 1994)

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