510(k) K150717

Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron by M/s. Meril Endo Surgery Private Limited. — Product Code GAM

K150717 is an FDA 510(k) premarket notification submitted by M/s. Meril Endo Surgery Private Limited. for the device "Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron". The FDA issued a decision of Substantially Equivalent on October 14, 2015. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. M/s. Meril Endo Surgery Private Limited. has at least 10 other 510(k) clearances on record.