# 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

- Pathway: 510(k) (Traditional)
- Applicant: M/s. Meril Endo Surgery Private Limited.
- Decided: May 31, 2016 after 88 days
- Product code: GAP (Suture, Nonabsorbable, Silk)
- Device class: 2
- Regulation: 21 CFR 878.5030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960327 (1996). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041514: Truesilk Non-Absorbable Silk Surgical Suture, Sutures India Private Limited (2005) Summary page 8.
- K041510: Trulon Non-Absorbable Polyamide Surgical Suture, Sutures India Private Limited (2005) Summary page 8.
- K041512: Nonabsorbable (Polyethylene Terephthalate) Surgical Suture, Sutures India Private Limited (2005) Summary page 8.
- K133356: Prolene Polypropylene Nonabsorbable Suture, ETHICON, Inc. (2013) Summary page 8.

## Most influential descendants
- K172149: 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 (2017), 1 descendant of its own
- K231183: Non absorbable Surgical Polyester Suture (2023), 0 descendants of its own

## Indications for use
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures. FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures. MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.

Source page: https://510kreport.com/device/K160623
Methodology: https://510kreport.com/methodology