Electrosurgical Coagulation Suction Tube

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K895337 ↗

FDA Product Code

HAM

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Chisel (Osteotome, Gouge, Etc.)

  Class I

  FDA 510(k) K864775 Active Cleared 12 Feb 1987

• Bipolar Micro Coagulator Models 25-1000 & 25-1200

  Class II

  FDA 510(k) K880863 Active Cleared 19 Apr 1988

• Bipolar Coagulating Forceps

  Class II

  FDA 510(k) K811820 Active Cleared 28 Jul 1981

• Bipolar Card

  Class II

  FDA 510(k) K831236 Active Cleared 2 Jun 1983

• Raney and Leroy-Raney Scalp Clip

  Class II

  FDA 510(k) K883963 Active Cleared 7 Oct 1988

• Cranio Blades and Wire Pass Drill

  Class I

  FDA 510(k) K861876 Active Cleared 30 May 1986

See all devices from New England Surgical Instrument Corp. →

• What is the electrosurgical coagulation suction tube used for?

  The device is used for coagulation and suction during surgical procedures, specifically in general and plastic surgery settings, as indicated in its FDA 510(k) clearance documentation.

• Is the electrosurgical coagulation suction tube sterile or non-sterile when supplied?

  The device is supplied non-sterile, as stated in the device data, and is intended for reusable use after appropriate cleaning and sterilization by the user.

• Is the electrosurgical coagulation suction tube designed for single-use or reusable applications?

  The device is intended for reusable use, meaning it can be cleaned, sterilized, and used multiple times following the manufacturer's reprocessing instructions.

• What regulatory pathway was used for the electrosurgical coagulation suction tube?

  The device received FDA 510(k) clearance under traditional pathway, with clearance number K895337, and is classified as an Apparatus, Electrosurgical under product code HAM and regulation number 878.4400.