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510(k) K032223

COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH by Cook Vascular, Inc. — Product Code GEI

K032223 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH". The FDA issued a decision of Substantially Equivalent on October 15, 2003. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Cook Vascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2003
Date Received
July 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Cook Vascular, Inc.

  • K142301 — Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sh (November 12, 2014)
  • K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTRO (July 1, 2014)
  • K110347 — DOPPLER MONITOR (March 16, 2011)
  • K083482 — COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET (April 2, 2009)
  • K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT (September 30, 2008)
  • K061000 — EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 (May 10, 2006)
  • K023937 — COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM (May 27, 2003)
  • K022649 — COOK-SWARTZ DOPPLER FLOW PROBE (September 6, 2002)
  • K010128 — COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE (April 25, 2002)
  • K002958 — SHAPEABLE DOPPLER FLOW PROBE (December 18, 2001)

Other clearances for product code GEI

  • K261179 — AlphaTriPart - Monopolar MIC Instruments (July 22, 2026)
  • K253504 — Volnewmer™ (July 13, 2026)
  • K254056 — THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 (July 1, 2026)
  • K251492 — Irrigation Tubing Bipolar Cord Set (June 29, 2026)
  • K253484 — LUTRONIC GENIUS (June 29, 2026)
  • K260636 — Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (June 18, 2026)
  • K253634 — CoolSeal Generator® (CSL-200-90) (June 17, 2026)
  • K261833 — NEUROMARK System (NMK00301) (June 16, 2026)
  • K253165 — LAP-iX2N (June 9, 2026)
  • K253656 — OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System (June 5, 2026)

FDA data resources