FDA 510k Submission - Sutures

Sutures are surgical threads or materials used to sew together tissues or wounds. They are classified based on several factors, including the material used, the size of the suture, the shape of the needle, and the intended use. Here are some common types of sutures:

  1. Absorbable sutures: These are sutures that break down and are absorbed by the body over time. They are typically made of materials like catgut, polyglycolic acid (PGA), or polylactic acid (PLA).

  2. Non-absorbable sutures: These are sutures that do not break down and are not absorbed by the body. They are typically made of materials like nylon, silk, or polyester.

  3. Monofilament sutures: These sutures are made of a single strand of material and are typically smooth, which can make them easier to handle. They can be either absorbable or non-absorbable.

  4. Multifilament sutures: These sutures are made of multiple strands of material that are twisted or braided together. They can be either absorbable or non-absorbable.

  5. Barbed sutures: These sutures have tiny, backward-facing barbs along the length of the suture, which help hold tissues together without the need for knots.

  6. Prolene sutures: These are non-absorbable sutures made of a synthetic material called polypropylene. They are commonly used for suturing skin and are known for their strength and durability.

  7. Vicryl sutures: These are absorbable sutures made of a copolymer of glycolide and lactide. They are commonly used for suturing soft tissues and have a moderate absorption rate.

  8. Silk sutures: These are non-absorbable sutures made of natural silk. They are known for their flexibility and ease of use.

  9. Stainless steel sutures: These are non-absorbable sutures made of stainless steel wire. They are often used in orthopedic surgery because of their strength and resistance to stretching.

FDA regulates sutures as class 2 and class 3 medical devices, which require pre-market approval or FDA 510K Clearance depending on the intended use of the suture. Medical device establishment registration and device listing are also needed to market the suture in the USA.

FDA Classification for Sutures

Regulation Number

Product Code

Suture Type

878.5035

PAW

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

876.1500

ODE

Endoscopic Suture

888.3030

NOV

Anchor, Suture, Bone Fixation, Metallic

878.4830

GAK

Suture, Absorbable

878.4830

GAL

Suture, Absorbable, Natural

Class 3

HHY

Prosthesis, Suture, Cerclage

Class 3

DTH

Suture, Cardiovascular

Class 3

DZG

Suture, Dental

Class 3

HMN

Suture, Nonabsorbable, Ophthalmic

Class 3

HMO

Suture, Absorbable, Ophthalmic

LMG Provides assistance to suture manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510k notification
  • Submission of 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your medical device establishment with FDA
  • List your suture with FDA.

Test requirements for sutures for US FDA 510K Submission

US FDA 510K Submission Requirements

FDA 510K Consultant