Home / 510(k) Clearances / K921405

510(k) K921405

DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP by Davol, Inc. — Product Code HFG

K921405 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP". The FDA issued a decision of Substantially Equivalent on March 25, 1994. The device falls under product code HFG (Coagulator, Laparoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Davol, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1994
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator, Laparoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by Davol, Inc.

  • K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped (June 12, 2025)
  • K250098 — Bard Soft Mesh; Bard Soft Mesh Pre-Shaped (April 9, 2025)
  • K031213 — AQUASENS FLUID MONITORING SYSTEM (April 30, 2003)
  • K030307 — DAVOL ARTHROVENT OUTFLOW TUBING (February 13, 2003)
  • K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (January 22, 2001)
  • K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, (December 22, 2000)
  • K931899 — DAVOL ATS (November 15, 1994)
  • K941334 — DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE (June 14, 1994)
  • K935503 — DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET (March 7, 1994)
  • K926479 — BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM (March 1, 1994)

Other clearances for product code HFG

  • K181124 — Acessa ProVu System (September 28, 2018)
  • K132744 — ACESSA GUIDANCE SYSTEM (May 27, 2014)
  • K132184 — ACESSA GUIDANCE HANDPIECE (April 28, 2014)
  • K121858 — THE ABLATION SYSTEM (November 5, 2012)
  • K101606 — MICROMED PD-8K INSULATION DEFECT DETECTOR (October 1, 2010)
  • K991424 — INSULSCAN INSULATION TESTING SYSTEM (July 22, 1999)
  • K961695 — ENDO-TECH LTD., TIPS (July 1, 1996)
  • K915406 — DAVOL ELECTROSUGICAL PROBES (February 28, 1992)
  • K904240 — SINGLE USE LAPARSCOPIC ELECTRODE (February 19, 1991)
  • K902555 — AMCATH COAGULATION PROBE (June 20, 1990)

FDA data resources