# K980703: Premilene Nonabsorbable Polypropylene Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 4, 1998 after 70 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Prolene® Nonabsorbable Polypropylene Surgical Suture: named in the summary without a submission number
- (no number) Surgilene® Nonabsorbable Polypropylene Surgical Suture: named in the summary without a submission number
- (no number) Sharpoint Polypropylene Surgical Suture: named in the summary without a submission number

## Most influential descendants
- K133890: Aesculap Optilene Nonabsorbable Suture (2014), 5 descendants of its own
- K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (2016), 3 descendants of its own
- K192420: Crownjun Nylon Suture (2020), 1 descendant of its own
- K221280: Vesseal (2022), 0 descendants of its own
- K212603: Non Absorbable Surgical Nylon Suture (2021), 0 descendants of its own

## Indications for use
Premilene® sutures are indicated for use in all types of general soft tissue approximation and ligation, including use in cardiovascular, ophthalmic, microsurgery and neural tissue.

Source page: https://510kreport.com/device/K980703
Methodology: https://510kreport.com/methodology