# K122734: Aesculap Novosyn Absorbable Suture

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Dec 18, 2012 after 103 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 K980704 (1998). 2 ancestors in all.
5 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)
- K980704: Safil Synthetic Absorbable Surgical Suture, Aesculap, Inc. (1998) Summary page 1.
- K022269: Coated Vicryl* (Polyglactin 910) Suture, ETHICON, Inc. (2002) Summary page 1.

## Most influential descendants
- K130735: Synthetic Absorbable Suture (2014), 3 descendants of its own
- K180027: ACCUSYTE 3D Fiducial Marker (2018), 0 descendants of its own
- K173043: Holycon Synthetic Absorbable Sutures (2017), 0 descendants of its own
- K170661: Novosyn Quick Absorbable Suture (2017), 0 descendants of its own
- K161629: Crylrex (2017), 0 descendants of its own

## Indications for use
Novosyn sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Source page: https://510kreport.com/device/K122734
Methodology: https://510kreport.com/methodology