ASTM F921-10 (Reapproved 2011)

Standard Organization:

ASTM F921-10 (Reapproved 2011)
Standard Terminology Relating to Hemostatic Forceps

Recognition Date2012-03-16
Recognition List028
Recognition Number6-268
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG General Plastic Surgery/General Hospital
FDA Tech  Long Chen   FDA/OMPT/CDRH/ODE/DSD/GSDB2/   301-796-6389   long.chen@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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 Guidance:

There is no relevant guidance developed at this time.


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