Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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6-469
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Standard | |
USP-NF M99650_02_01 <861> Sutures - Diameter |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§878.4493 |
Suture, Absorbable, Synthetic, Polyglycolic Acid
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Class 2
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GAM
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§878.4494 |
Suture, Recombinant Technology
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Class 2
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NWJ
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§878.4495 |
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
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Class 2
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GAQ
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§878.4495 |
Suture, Nonabsorbable, Nitinol
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Class 2
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NJU
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§878.4830 |
Suture, Absorbable, Natural
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Class 2
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GAL
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§878.4840 |
Suture, Surgical, Absorbable, Polydioxanone
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Class 2
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NEW
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§878.5000 |
Suture, Nonabsorbable, Synthetic, Polyethylene
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Class 2
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GAT
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§878.5010 |
Suture, Nonabsorbable, Synthetic, Polypropylene
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Class 2
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GAW
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§878.5010 |
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
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Class 2
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MXW
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§878.5020 |
Suture, Nonabsorbable, Synthetic, Polyamide
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Class 2
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GAR
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§878.5030 |
Suture, Nonabsorbable, Silk
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Class 2
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GAP
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§878.5035 |
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
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Class 2
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NBY
|
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Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff, issued June 2003.
Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology - Guidance for Industry and FDA Staff, issue August 2007.
DOI: https://doi.org/10.31003/USPNF_M99650_02_01.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |
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