Electrosurgical Meniscus Cutter Mod. AMC-100

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Electrosurgical Meniscus Cutter (Emc) Mod. Amc-100

510(k) Number

K870269 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gasline Filter #gf-10

  Class I

  FDA 510(k) K832411 Active Cleared 12 Sep 1983

• Electrosurgical Lateral Release Probe Mod Alr-100

  Class II

  FDA 510(k) K852683 Active Cleared 12 Aug 1985

• Integrated Membrane Oxygenator W/Cardiotomy Filter

  Class II

  FDA 510(k) K873923 Active Cleared 6 Nov 1987

• Oxygen Monitor No. OM-100, Oxygen Probe No. OP-100

  Class II

  FDA 510(k) K860106 Active Cleared 26 Feb 1986

• Adjustable Oxygenator Holder Model No. Bcm-Hl

  Class I

  FDA 510(k) K860672 Active Cleared 3 Mar 1986

• Cardioplegia Heat Exchanger Holder He-100SH

  Class I

  FDA 510(k) K854113 Active Cleared 8 Jan 1986

See all devices from American Bentley →

• What types of surgical procedures is the AMC-100 Electrosurgical Meniscus Cutter primarily used for?

  The AMC-100 is specifically designed for meniscus tissue resection, a procedure commonly performed in orthopaedic surgery. Its electrosurgical capabilities allow for precise cutting and coagulation of meniscus tissue, making it suitable for surgeries involving the knee joint where meniscus repair or removal is required.

• Is the AMC-100 a single-use or reusable device, and what maintenance considerations should be kept in mind?

  The AMC-100 is a reusable medical instrument, meaning it is intended for repeated use in controlled surgical environments. Since it is reusable, proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality. Adherence to standard electrosurgical safety protocols, including grounding and insulation checks, is also essential to prevent electrical hazards during use.

• How is the AMC-100 Electrosurgical Meniscus Cutter regulated, and what does its clearance status mean?

  The AMC-100 received FDA 510(k) clearance under the traditional review pathway, meaning it was determined to be substantially equivalent to a predicate device already on the market. This clearance confirms its compliance with U.S. regulatory standards for electrosurgical devices used in general and plastic surgery (product code GEI). The clearance date is March 9, 1987, with the K-number K870269 for reference.

• What safety measures must be followed when using the AMC-100 in the operating room?

  The AMC-100 requires adherence to standard electrosurgical safety protocols, including proper grounding of the patient and ensuring adequate insulation to prevent electrical hazards. Since it operates using electrosurgical energy, the surgical team must follow established guidelines for safe handling, such as avoiding contact with non-insulated surfaces and verifying the integrity of the device before use.