510(k) · Cleared
ClearedAilee Sutures and Ailee Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myco Medical Supplies, Inc. · GAL Suture, Absorbable, Natural
Cleared on Jun 2, 1999 after a 308-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jun 2, 1999
- Review
- 308 days
- Class
- Class II
- Product code
- GAL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK982646 Ailee Sutures and Ailee NeedlesMyco Medical Supplies, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK161633 Rexlon, RexsilSm Eng Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK180701 SafePath Suturing SystemSafepath Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK222944 SafePath Sulturing System-Silk Suture, SafePath Sulturing System…Safepath Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK232355 Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK212888 Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures · 2022
Most influential descendants
Showing 5 of 5 · See all- K161633Rexlon, RexsilSm Eng Co., Ltd. · 2017 · cites it directly4descendants
- K180701SafePath Suturing SystemSafepath Medical, Inc. · 2018 · 2 generations on1descendant
- K222944SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture…Safepath Medical, Inc. · 2024 · 2 generations on0descendants
- K232355Non absorbable Surgical Silk SutureShandong Haidike Medical Product Co., Ltd. · 2024 · 2 generations on0descendants
- K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982646 | Ailee Sutures and Ailee Needles | Myco Medical Supplies, Inc. | 1999 | — |
| +1 | K161633 | Rexlon, Rexsil | Sm Eng Co., Ltd. | 2017 | — |
| +2 | K180701 | SafePath Suturing System | Safepath Medical, Inc. | 2018 | — |
| +2 | K222944 | SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide… | Safepath Medical, Inc. | 2024 | — |
| +2 | K232355 | Non absorbable Surgical Silk Suture | Shandong Haidike Medical Product Co., Ltd. | 2024 | — |
| +2 | K212888 | Golnit Nylon Monofilament Suture | Antarma, LLC Dba Golnit Sutures | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAL? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161633 | Rexlon, Rexsil | 2017 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K161633 (Sm Eng Co., Ltd., 2017) has gone furthest, with 4 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 | — |
What is it indicated for?
Chromic Gut surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neural tissue. Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neural tissue. Polyglycolic acid…
Read the full statement (187 words)
Chromic Gut surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neural tissue.
Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neural tissue.
Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues.
Silk sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982646: Ailee Sutures and Ailee Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982646
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026