# K000037: Monofilament Biosyn Suture

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Mar 30, 2000 after 84 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
94 later devices descend from it; 5 cite it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), 44 descendants of its own
- K013671: L-25 Absorbable Surigcal Suture (2002), 43 descendants of its own
- K040477: Monoderm (2004), 29 descendants of its own

## Recalls of this device
- Dec 18, 2019 · Class II · Z-1278-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1284-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1285-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1276-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1279-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1296-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1277-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1295-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1288-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1287-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1280-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1283-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1297-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1300-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1299-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1294-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1290-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1292-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1291-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1274-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1281-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1298-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1282-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1275-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1293-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1289-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- Dec 18, 2019 · Class II · Z-1286-2020: There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
- May 3, 2017 · Class II · Z-2544-2017: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Source page: https://510kreport.com/device/K000037
Methodology: https://510kreport.com/methodology