# K980704: Safil Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 11, 1998 after 77 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 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) DEXON® Synthetic Absorbable Surgical Suture (Davis & Geck): named in the summary without a submission number
- (no number) VICRYL® Synthetic Absorbable Surgical Suture (Ethicon, Inc.): named in the summary without a submission number
- (no number) POLYSORB® Synthetic Absorbable Surgical Suture (U. S. Surgical Corp.): named in the summary without a submission number

## Most influential descendants
- K122734: Aesculap Novosyn Absorbable Suture (2012), 5 descendants of its own
- K130735: Synthetic Absorbable Suture (2014), 3 descendants of its own
- K031286: Safil and Safil Quick Synthetic Absorbable Surgical Suture (2003), 3 descendants of its own
- K061796: Hepatostat Set, Model 760X (2006), 1 descendant of its own
- K233265: Monotime and Optime R (2024), 0 descendants of its own

## Indications for use
Safil® sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery, microsurgery or neural tissue.

Source page: https://510kreport.com/device/K980704
Methodology: https://510kreport.com/methodology