# K990952: Novafil** and Vascufil** Sterile Synthetic Non-Absorbable Sutures

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Apr 1, 1999 after 10 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Novafil**: named in the summary without a submission number
- (no number) Vascufil**: named in the summary without a submission number

## Most influential descendants
- K103052: V-Loc (TM) Nonabsorbable Wound Closure Device (2010), 3 descendants of its own
- K211792: StitchKit (2021), 1 descendant of its own
- K221527: StitchKit (2023), 0 descendants of its own
- K111442: V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM) Endoscopic Suturing Device, Sils (TM)... (2011), 0 descendants of its own
- K013990: Lifestitch Suturing Device (2002), 0 descendants of its own

## Recalls of this device
- Dec 2, 2022 · Class II · Z-1181-2023: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
- Dec 2, 2022 · Class II · Z-1175-2023: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

## Indications for use
Novafil** and Vascufil** sutures are indicated for use as non-absorbable sutures in general and soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic surgery, but not in microsurgery and neural tissue.

Source page: https://510kreport.com/device/K990952
Methodology: https://510kreport.com/methodology