510(k) · Cleared
Recalled · Class II · 2014Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deknatel, Inc. · GAL Suture, Absorbable, Natural
Cleared on Jul 26, 1994 after a 529-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 232 devices in its family, counting itself, has a Class I recall. 231 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 26, 1994
- Review
- 529 days
- Class
- Class II
- Product code
- GAL
- Recalls
- 9
- Predicates
- 0
231 later devices descend from it, 9 citing it directly. 1 of the 232 devices in this family, counting this one, has a Class I recall.
- This deviceK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994
- Descendant · cites it directly · 138 of its ownK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- Descendant · cites it directly · 105 of its ownK993415 GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10…Boston Scientific, Target · 2000
- Descendant · 2 generations on · 103 of its ownK022420 Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002
- Descendant · 2 generations on · 96 of its ownK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- Descendant · 3 generations on · 91 of its ownK031578 Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp. · 2003
Showing 5 of 231 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…6 generations on · 2022
Most influential descendants
Showing 5 of 231 · See all- K991139Guglielmi Detachable (GDC)Boston Scientific, Target · 1999 · cites it directly138descendants
- K993415GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Boston Scientific, Target · 2000 · cites it directly105descendants
- K022420Micrus Stretch-Resistant Microcoil System, MSR01Micrus Corp. · 2002 · 2 generations on103descendants
- K012145Microplex Coil SystemMicroVention, Inc. · 2001 · 2 generations on96descendants
- K031578Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRMicrus Corp. · 2003 · 3 generations on91descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | — |
| +1 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| +1 | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch… | Boston Scientific, Target | 2000 | — |
| +2 | K022420 | Micrus Stretch-Resistant Microcoil System, MSR01 | Micrus Corp. | 2002 | — |
| +2 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| +3 | K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSR | Micrus Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 14 | 0 |
| 2010 | 15 | 0 |
| 2011 | 14 | 0 |
| 2012 | 16 | 0 |
| 2013 | 13 | 0 |
| 2014 | 7 | 0 |
| 2015 | 16 | 0 |
| 2016 | 12 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 10 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 1 |
| 2023 | 5 | 0 |
| 2024 | 11 | 0 |
| 2025 | 9 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (231)
See all 2319 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991139 | Guglielmi Detachable (GDC) | 1999 | 138 |
| K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant… | 2000 | 105 |
| K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | 2002 | 49 |
| K070673 | Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture | 2007 | 23 |
| K031443 | Lsi Solutions Suture Quick Load Products | 2003 | 7 |
| K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX… | 2016 | 4 |
| K193530 | Deklene MAXX | 2020 | 0 |
| K120284 | Digitex Suture Delivery System, Digitexpolypropylene Suture Cartridge Size 0, with… | 2012 | 0 |
| K981322 | Cutalon Nylon Polyamide Surgical Suture | 1998 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2014 | Class II | Z-1555-2014 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Employee error | 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 | Other | The products are being recalled because they did not meet minimum diameter requirements. |
| Mar 11, 2014 | Class II | Z-1559-2014 | Employee error | 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 | Other | 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. |
The 5 latest of 9 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 6 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K991139 (Boston Scientific, Target, 1999) has gone furthest, with 138 descendants of its own.
How does its category compare?
All GAL devicesGAL Suture, Absorbable, Natural: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAL
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · GAL
Too few GAL 510(k)s in any year since 2007 to give a median.
Recalls per year · GAL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAL
117in 2025
MAUDE reports naming product code GAL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 13 |
| 2008 | 1 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 25 |
| 2010 | 0 | — | 0 | 57 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 0 | — | 0 | 157 |
| 2015 | 1 | — | 0 | 137 |
| 2016 | 0 | — | 0 | 87 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 0 | — | 0 | 246 |
| 2019 | 0 | — | 1 | 229 |
| 2020 | 0 | — | 0 | 109 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 130 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 117 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K930738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930738: Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930738
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026