174 Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedur

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Appendix A F. No. 29/Misc./03/2022-DC (228) Government of India Directorate General of Health Services Ministry of Health & Family Welfare Central Drugs Standard Control Organisation (Medical Devices Division)

FDA Bhawan, Kotla Road, New Delhi- 110002

Notice

Classification of Medical Devices pertaining to non-sterile, non- powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures

‘Non-Sterile and Invasive Surgical Instruments’ are commonly intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be used after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.

S. No. Name of the Medical Devices Intended Use Risk Classification 1 Cutting and Dissecting Surgical instruments
These are transient use invasive surgical instruments, usually have sharp edges or tips to cut through skin, tissue, and suture material. Intended to cut and dissect tissue to explore irregular growths and to remove dangerous or damaged tissue. Also used for cutting sutures.
A 2 Clamping and Occluding Surgical instruments These are transient use invasive surgical instruments, intended for use in many surgical procedures for compressing blood vessels or hollow organs. In order to prevent their contents from leaking or control bleeding or Occlude. They are designed straight, curved or angled, or ratcheted and have a variety of inner jaw patterns. A

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3 Retracting and Exposing Surgical instruments These are transient use invasive surgical instruments, intended to hold back, or retract organs and tissue, or other article to have access to the operative area during surgical procedure. They spread open the skin, ribs and other tissues; and are also used separate the edges of a surgical incision. A 4 Grasping and Holding Surgical instruments These transient use invasive surgical instruments are intended to grasp and hold tissue or blood vessels that may be in the way during a surgical procedure. Designed serrated or non-serrated at the tip. A

Note for clarification:

1. “transient use” means a device intended for continuous use for less than sixty minutes.
2. “invasive device” means a device which, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body.