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510(k) K980804

SABRE BT BLUNT0TIP SURGICAL TROCAR by Endoscopic Concepts, Inc. — Product Code FBQ

K980804 is an FDA 510(k) premarket notification submitted by Endoscopic Concepts, Inc. for the device "SABRE BT BLUNT0TIP SURGICAL TROCAR". The FDA issued a decision of Substantially Equivalent on April 1, 1998. The device falls under product code FBQ (Trocar, Gastro-Urology), a Class II device regulated under 21 CFR 876.5090. Endoscopic Concepts, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1998
Date Received
March 2, 1998
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 Endoscopic Concepts, Inc.

  • K952977 — SABRE MULTI-USE TROCAR SYSTEM (July 17, 1995)
  • K950500 — BASIC REUSABLE TROCAR SYSTEM (February 23, 1995)
  • K943976 — SABRE ULTIMATE SHIELDED TROCAR (September 7, 1994)

Other clearances for product code FBQ

  • K012198 — GIBBONS STERILE TROCAR KITS (August 9, 2001)
  • 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)

FDA data resources