# P010003: Bioglue Surgical Adhesive

- Pathway: PMA
- Applicant: Cryolife, Inc.
- Decided: Dec 3, 2001 after 304 days
- Product code: MUQ (Glue, Surgical, Arteries)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 7, 2021 · Class II · Z-0384-2022: Product is not approved for use in the EU and should not have been distributed in the EU.
- Jun 4, 2018 · Class II · Z-2556-2018: The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included 
- May 19, 2017 · Class II · Z-2623-2017: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
- Apr 25, 2014 · Class II · Z-1674-2014: Serum albumin component monomer failed to meet internally established end of shelf-life specification.

Source page: https://510kreport.com/device/P010003
Methodology: https://510kreport.com/methodology