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510(k) K910218

LAPAROMED CHOLANGIOGRAM VACUUM DEVICE by Laparomed Corp. — Product Code GCX

K910218 is an FDA 510(k) premarket notification submitted by Laparomed Corp. for the device "LAPAROMED CHOLANGIOGRAM VACUUM DEVICE". The FDA issued a decision of Substantially Equivalent on April 8, 1991. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Laparomed Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1991
Date Received
January 17, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Laparomed Corp.

  • K934527 — FASCIA STITCHER (February 25, 1994)
  • K930569 — LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEM (April 20, 1993)
  • K921921 — CATHETER CHOLANGIOGRAPHY (August 17, 1992)
  • K921053 — LAPAROMED LIGATING LOOP (August 6, 1992)
  • K921006 — LAPAROSCOPIC RETRACTOR SYSTEM (July 28, 1992)
  • K914066 — ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS (November 7, 1991)
  • K910074 — LAPAROMED HOOK/SPATULA DEVICE (July 2, 1991)
  • K910219 — LAPAROMED CHOLANGIOGRAM DEVICE (April 8, 1991)
  • K905722 — SUTURE APPLIER DEVICE (March 14, 1991)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources