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510(k) K911462

SURGICAL TROCAR by Applied Medical — Product Code DRC

K911462 is an FDA 510(k) premarket notification submitted by Applied Medical for the device "SURGICAL TROCAR". The FDA issued a decision of Substantially Equivalent on April 22, 1991. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Applied Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
April 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

Other clearances by Applied Medical

  • K202818 — Voyant Fine Fusion Device (EB230) (December 16, 2021)
  • K191866 — GelPOINT Mini Advanced Access Platform (April 29, 2020)
  • K122619 — EPIX IRRIGATION PUMP, EPIX SUCTION IRRIGATION TUBING SET (October 2, 2012)
  • K070865 — EXPANDING VASCULAR SHEATH (October 23, 2007)
  • K003443 — SUCTION IRRIGATOR (February 1, 2001)
  • K002915 — FLEXIBLE OCCLUSION SYSTEM (January 8, 2001)
  • K915826 — BIO-POLAR FORCEPS (June 2, 1992)
  • K844677 — APPLIED GAUZE SPONGE 2X2X12 (April 1, 1985)
  • K844726 — GAUZE SPONGE 4X4X12 PLY (April 1, 1985)
  • K844675 — APPLIED GAUZE SPONGE 3X3X12 (April 1, 1985)

Other clearances for product code DRC

  • K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230) (July 26, 2024)
  • K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) (May 17, 2024)
  • K221707 — SafeSept® Transseptal Guidewire (SS-140) (September 14, 2022)
  • K212625 — PathBuilder Transseptal Needle (March 23, 2022)
  • K210328 — SafeSept Blunt Needle (March 5, 2021)
  • K172950 — TSN Transseptal Needle (February 21, 2018)
  • K172934 — Needle Free Transseptal Cannula (February 16, 2018)
  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
  • K170671 — SafeSept Transseptal Guidewire (October 20, 2017)
  • K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (August 29, 2014)

FDA data resources