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510(k) K011988

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C by Cardiofocus, Inc. — Product Code OCL

K011988 is an FDA 510(k) premarket notification submitted by Cardiofocus, Inc. for the device "SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C". The FDA issued a decision of Substantially Equivalent on September 20, 2001. The device falls under product code OCL (Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue), a Class II device regulated under 21 CFR 878.4400. Cardiofocus, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2001
Date Received
June 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Other clearances by Cardiofocus, Inc.

  • K152310 — HeartLight Deflectable Sheath (February 24, 2016)
  • K013201 — CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (March 18, 2002)
  • K013901 — MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (December 20, 2001)
  • K993834 — SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (February 4, 2000)

Other clearances for product code OCL

  • K252056 — Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) (July 24, 2025)
  • K234151 — Isolator Synergy EnCapture Ablation System (EMH) (August 27, 2024)
  • K221358 — Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® L (December 30, 2022)
  • K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 (December 22, 2022)
  • K210477 — AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE (July 26, 2021)
  • K211311 — AtriCure Isolator® Synergy™ Surgical Ablation System (May 28, 2021)
  • K200514 — Cardioblate Gemini-s Surgical Ablation Device (June 3, 2020)
  • K193162 — EPi-Sense Guided Coagulation System with VisiTrax (December 13, 2019)
  • K192125 — Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen (November 4, 2019)
  • K191526 — Cardioblate CryoFlex Surgical Ablation System (October 1, 2019)

FDA data resources