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510(k) K940171

CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM by Cabot Medical Corp. — Product Code DWJ

K940171 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 9, 1994. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1994
Date Received
January 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Cabot Medical Corp.

  • K960148 — CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT (March 25, 1996)
  • K946109 — CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS (November 21, 1995)
  • K951972 — CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SH (July 21, 1995)
  • K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (July 11, 1995)
  • K941743 — CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP (April 19, 1995)
  • K934115 — 3000 ELECTRONIC INSUFFLATOR MODIFICATION (March 15, 1995)
  • K932293 — CABOT MEDICAL BIPOLAR CUTTING FORCEPS (July 27, 1994)
  • K930954 — THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV (June 30, 1994)
  • K932626 — CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB (June 8, 1994)
  • K935786 — CORSON AND NEZHAT SUCTION/IRRIGATION PROBES (May 19, 1994)

Other clearances for product code DWJ

  • K260278 — ThermAffyx(TM) Patient Safety System (July 8, 2026)
  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K252861 — Warming System (April 7, 2026)
  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K242964 — Celsi Warmer (June 20, 2025)
  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)
  • K231211 — Medline ComfortTemp Patient Warming System (December 1, 2023)
  • K232638 — FilteredFlo Warming Blankets (October 24, 2023)

FDA data resources