# K172659: MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly (glycolide-co-caprolactone) Surgical Suture

- Pathway: 510(k) (Special)
- Applicant: M/s. Meril Endo Surgery Private Limited.
- Decided: Sep 28, 2017 after 23 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K150717 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150717: Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron, M/s. Meril Endo Surgery Private Limited. (2015) Summary page 5.

## Indications for use
MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures. MITSU suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures. FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K172659
Methodology: https://510kreport.com/methodology