Recognized Consensus Standards

Recognition List Number: 030 Publication Date: 01/15/2013 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-288: USP 35-NF30 <871>, Sutures - Needle Attachment. (General Plastic Surgery/General Hospital)

Date of Standard: 2012. 

Address of Standards Organization:

  United States Pharmacopeial Convention, Inc. (USP)

  12601 Twinbrook Parkway

  Rockville, MD 20852

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Absorbable and Nonabsorbable Surgical Sutures

Processes Affected:

510(k), IDE, PMA

Type of Standard:

 National, Vertical

Extent of Recognition:

Complete Standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Suture, Nonabsorbable	Class U	GAO
Regulation Number	Device Name	Device Class	Product Code
§878.4493	Suture, Absorbable, Synthetic, Polyglycolic Acid	Class 2	GAM
Regulation Number	Device Name	Device Class	Product Code
§878.4494	Suture, Recombinant Technology	Class 2	NWJ
Regulation Number	Device Name	Device Class	Product Code
§878.4495	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	Class 2	GAQ
Regulation Number	Device Name	Device Class	Product Code
§878.4830	Suture, Absorbable	Class 2	GAK
§878.4830	Suture, Absorbable, Natural	Class 2	GAL
§878.4830	Suture, Absorbable, Synthetic	Class 2	GAN
Regulation Number	Device Name	Device Class	Product Code
§878.4840	Suture, Surgical, Absorbable, Polydioxanone	Class 2	NEW
Regulation Number	Device Name	Device Class	Product Code
§878.5000	Suture, Nonabsorbable, Synthetic, Polyester	Class 2	GAS
§878.5000	Suture, Nonabsorbable, Synthetic, Polyethylene	Class 2	GAT
Regulation Number	Device Name	Device Class	Product Code
§878.5010	Suture, Nonabsorbable, Synthetic, Polypropylene	Class 2	GAW
Regulation Number	Device Name	Device Class	Product Code
§878.5020	Suture, Nonabsorbable, Synthetic, Polyamide	Class 2	GAR
Regulation Number	Device Name	Device Class	Product Code
§878.5030	Suture, Nonabsorbable, Silk	Class 2	GAP
Regulation Number	Device Name	Device Class	Product Code
§878.5035	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	Class 2	NBY

Relevant Guidance:

Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA. Issued June 3, 2003

Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology: Guidance for Industry and FDA. Issued August 3, 2007

FDA Technical Contact:

  Maegen Colehour

  FDA/CDRH/ODE

  10903 New Hampshire Building 66, Room G423

  Silver Spring MD 20993

  301/796-6436

  Email: maegen.colehour@fda.hhs.gov