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510(k) K012198

GIBBONS STERILE TROCAR KITS by Gibbons Surgical Corp. — Product Code FBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2001
Date Received
July 13, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Gastro-Urology
Device Class
Class II
Regulation Number
876.5090
Review Panel
SU
Submission Type

Other clearances by Gibbons Surgical Corp.

  • K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (April 10, 2001)

Other clearances for product code FBQ

  • K980804 — SABRE BT BLUNT0TIP SURGICAL TROCAR (April 1, 1998)
  • K944640 — LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (October 11, 1994)
  • K944104 — GABRIS LAPAROSCOPIC SURGICAL KITS (September 13, 1994)
  • K942885 — AUTO SUTURE MODIFIED GRIP (August 22, 1994)
  • K934724 — AESCULAP TROCAR INSTRUMENT SET (December 23, 1993)
  • K904638 — TROCAR DISPOSABLE (February 21, 1991)
  • K900123 — AUTO SUTURE SURGIPORT SPIRAL SLEEVE (April 4, 1990)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)