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510(k) K944104

GABRIS LAPAROSCOPIC SURGICAL KITS by Gabris Surgical Corp. — Product Code FBQ

K944104 is an FDA 510(k) premarket notification submitted by Gabris Surgical Corp. for the device "GABRIS LAPAROSCOPIC SURGICAL KITS". The FDA issued a decision of Substantially Equivalent on September 13, 1994. The device falls under product code FBQ (Trocar, Gastro-Urology), a Class II device regulated under 21 CFR 876.5090. Gabris Surgical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1994
Date Received
August 23, 1994
Clearance Type
Traditional
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 Gabris Surgical Corp.

  • K954774 — SHIELDED TROCAR (OBTURATOR) (June 7, 1996)
  • K953548 — LAPAROSCOPIC SURGICAL INSTRUMENT (September 19, 1995)
  • K944640 — LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (October 11, 1994)
  • K944103 — LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (September 12, 1994)
  • K943989 — LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (September 12, 1994)
  • K930716 — LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION (July 23, 1993)

Other clearances for product code FBQ

  • K012198 — GIBBONS STERILE TROCAR KITS (August 9, 2001)
  • K980804 — SABRE BT BLUNT0TIP SURGICAL TROCAR (April 1, 1998)
  • K944640 — LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (October 11, 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)

FDA data resources