# K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc

- Pathway: 510(k) (Traditional)
- Applicant: Deknatel, Inc.
- Decided: Jul 26, 1994 after 529 days
- Product code: GAL (Suture, Absorbable, Natural)
- Device class: 2
- Regulation: 21 CFR 878.4830
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
231 later devices descend from it; 9 cite it directly.
1 of 232 devices in its family (counting itself) has 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
- K991139: Guglielmi Detachable (GDC) (1999), 138 descendants of its own
- K993415: GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant Guglielmi Detachable Coil, GDC-1 (2000), 105 descendants of its own
- K022420: Micrus Stretch-Resistant Microcoil System, MSR01 (2002), 103 descendants of its own
- K012145: Microplex Coil System (2001), 96 descendants of its own
- K031578: Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR (2003), 91 descendants of its own

## Recalls of this device
- Mar 11, 2014 · Class II · Z-1555-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Mar 11, 2014 · Class II · Z-1560-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Mar 11, 2014 · Class II · Z-1558-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Mar 11, 2014 · Class II · Z-1557-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Mar 11, 2014 · Class II · Z-1556-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Mar 11, 2014 · Class II · Z-1561-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Mar 11, 2014 · Class II · Z-1497-2014: The products are being recalled because they did not meet minimum diameter requirements.
- Mar 11, 2014 · Class II · Z-1559-2014: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
- Jun 6, 2007 · Not classified · Z-1018-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Source page: https://510kreport.com/device/K930738
Methodology: https://510kreport.com/methodology