| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
028
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Date of Entry 03/16/2012
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|
FR Recognition Number
|
6-269
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| Standard | |
ASTM F1078-10 (Reapproved 2018)
Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
|
Scope/Abstract| 1.1 This terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures. |
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| Extent of Recognition
|
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 |
| §872.4565 |
Scissors, Surgical Tissue, Dental
|
Class 1
|
EGN
|
| §878.4800 |
Scissors, General, Surgical
|
Class 1
|
LRW
|
| §880.6820 |
Scissors, Medical, Disposable
|
Class 1
|
JOK
|
| §888.4540 |
Scissors, Orthopedic, Surgical
|
Class 1
|
HRR
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
|
| *These are provided as examples and others may be applicable. |
