ASTM F921-10 (Reapproved 2011) Standard Terminology Relating to Hemostatic Forceps |
Recognition Date | 2012-03-16 |
Recognition List | 028 |
Recognition Number | 6-268 |
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 |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
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 |
There is no relevant guidance developed at this time. |