510(k) K821697

INJECTION ASPIRATING NEEDLES by American Endoscopy, Inc. — Product Code GAA

K821697 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "INJECTION ASPIRATING NEEDLES". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. American Endoscopy, Inc. has at least 10 other 510(k) clearances on record.