510(k) K160623

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture by M/s. Meril Endo Surgery Private Limited. — Product Code GAP

K160623 is an FDA 510(k) premarket notification submitted by M/s. Meril Endo Surgery Private Limited. for the device "FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture". The FDA issued a decision of Substantially Equivalent on May 31, 2016. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. M/s. Meril Endo Surgery Private Limited. has at least 10 other 510(k) clearances on record.