Home / 510(k) Clearances / K904638

510(k) K904638

TROCAR DISPOSABLE by L.A.S.E.R., Inc. — Product Code FBQ

K904638 is an FDA 510(k) premarket notification submitted by L.A.S.E.R., Inc. for the device "TROCAR DISPOSABLE". The FDA issued a decision of Substantially Equivalent on February 21, 1991. The device falls under product code FBQ (Trocar, Gastro-Urology), a Class II device regulated under 21 CFR 876.5090. L.A.S.E.R., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
October 11, 1990
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 L.A.S.E.R., Inc.

  • K983965 — CO2 LASER COUPLER (December 22, 1998)
  • K950021 — REUSABLE TROCAR WITH SAFETY SLEEVE (March 31, 1995)
  • K940454 — GRASPING FORCEPS, PUNCHES, SCISSORS (March 25, 1994)
  • K931561 — TROCAR SLEEVE (February 7, 1994)
  • K933421 — ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES (November 2, 1993)
  • K924844 — BULK TISSUE REMOVAL SYSTEM (October 8, 1993)
  • K932045 — DISPOSABLE INSUFFLATION TUBING (September 23, 1993)
  • K931092 — ENDOSCOPIC RETRACTOR (April 30, 1993)
  • K914197 — ALLOY SCALPEL HANDPIECES (April 10, 1992)
  • K892912 — MODEL JM-1 CO2 LASER (March 6, 1990)

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)
  • K944104 — GABRIS LAPAROSCOPIC SURGICAL KITS (September 13, 1994)
  • K942885 — AUTO SUTURE MODIFIED GRIP (August 22, 1994)
  • K934724 — AESCULAP TROCAR INSTRUMENT SET (December 23, 1993)
  • K900123 — AUTO SUTURE SURGIPORT SPIRAL SLEEVE (April 4, 1990)
  • K841716 — ENDOPORT EROCAR (June 28, 1984)

FDA data resources