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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Entry 03/16/2012 
FR Recognition Number 6-268
Standard
ASTM F921-10 (Reapproved 2018)
Standard Terminology Relating to Hemostatic Forceps
Scope/Abstract
1.1 This terminology covers basic terms and considerations for the components of hemostatic forceps. Instruments in this terminology are limited to those fabricated from stainless steel and for general surgical procedures. See Fig. 1 and Fig. 2.
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4800 Forceps Class 1 HTD
§878.4800 Forceps, General & Plastic Surgery Class 1 GEN
§872.4565 Hemostat, Surgical Class 1 EMD
FDA Technical Contact
 Long Chen
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVA/
  301-796-6389
  long.chen@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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