# K031286: Safil and Safil Quick Synthetic Absorbable Surgical Suture

- Pathway: 510(k) (Special)
- Applicant: Aesculap, Inc.
- Decided: May 29, 2003 after 36 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944110 (1995). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011372: Aesculap, Inc. Safil Quick Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2001)
- K980704: Safil Synthetic Absorbable Surgical Suture, Aesculap, Inc. (1998) Summary page 1.
- K944110: Vicryl Rapide Suture, ETHICON, Inc. (1995) Summary page 1.
- K962480: Coated Vicryl Rapide (Polyglactin 910) Braided, Synthetic Absorbable Suture, Undyed, ETHICON, Inc. (1996) Summary page 1.
- K011375: Aesculap, Inc., Monosyn Synthetic Absorbable Surgical Suture, Aesculap, Inc. (2001)

## Most influential descendants
- K061796: Hepatostat Set, Model 760X (2006), 1 descendant of its own
- K233265: Monotime and Optime R (2024), 0 descendants of its own
- K073493: Hepatostat Set (2008), 0 descendants of its own

## Recalls of this device
- Aug 1, 2016 · Class II · Z-0316-2017: There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a seco

## Indications for use
Safil and Safil Quick sutures are indicated for use in general soft tissue approximation, including ophthalmic procedures, but not in cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K031286
Methodology: https://510kreport.com/methodology