510(k) · Cleared
ClearedFILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M/s. Meril Endo Surgery Private Limited. · GAP Suture, Nonabsorbable, Silk
Cleared on May 31, 2016 as substantially equivalent to K041514 (Sutures India Private Limited, 2005) and 3 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- May 31, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- GAP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K960327 (1996). 10 ancestors in all, the oldest K946173 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960327 Nylon Noabsorbable Surgical Sutures UspR. K. Medical L. L. C. · 1996
- 1 generation backK041510 Trulon Non-Absorbable Polyamide Surgical SutureSutures India Private Limited · 2005
- This deviceK160623 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2016
- Descendant · cites it directly · 1 of its ownK172149 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE -…M/s. Meril Endo Surgery Private Limited. · 2017
- Descendant · 2 generations on · 0 of its ownK231183 Non absorbable Surgical Polyester SutureShandong Haidike Medical Products Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960327 | Nylon Noabsorbable Surgical Sutures Usp | R. K. Medical L. L. C. | 1996 | — |
| −1 | K041510 | Trulon Non-Absorbable Polyamide Surgical Suture | Sutures India Private Limited | 2005 | — |
| 0 (this device) | K160623 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2016 | — |
| +1 | K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non… | M/s. Meril Endo Surgery Private Limited. | 2017 | — |
| +2 | K231183 | Non absorbable Surgical Polyester Suture | Shandong Haidike Medical Products Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAP device
- #1 K222944 SafePath Sulturing System-Silk Suture…score 9.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041514 | Truesilk Non-Absorbable Silk Surgical SutureSummary page 8…Device 510(k) No. 1. FILASILKTM Natural Non- TRUSILK K041514 absorbable Silk Surgical Suture 2. FILAMIDETM Non Absorbable TRULON K0… | 2005 |
| * | K041510 | Trulon Non-Absorbable Polyamide Surgical SutureSummary page 8…atural Non- TRUSILK K041514 absorbable Silk Surgical Suture 2. FILAMIDETM Non Absorbable TRULON K041510 Polyamide Surgical Sutures 3. MERICRON XLTM Non TRUBOND K041512… | 2005 |
| * | K041512 | Nonabsorbable (Polyethylene Terephthalate) Surgical SutureSummary page 8…n Absorbable TRULON K041510 Polyamide Surgical Sutures 3. MERICRON XLTM Non TRUBOND K041512 Absorbable Polyester Surgical Suture 4. FILAPROPTM Non Absorbable… | 2005 |
| * | K133356 | Prolene Polypropylene Nonabsorbable SutureSummary page 8…K041512 Absorbable Polyester Surgical Suture 4. FILAPROPTM Non Absorbable PROLENE K133356 Polypropylene Surgical Suture IV. Device Description a. FILASILKTM Natural Non-absorbable Silk Surg… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172149 | FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable… | 2017 | 1 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K172149 (M/s. Meril Endo Surgery Private Limited., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K041514.
How does its category compare?
All GAP devicesGAP Suture, Nonabsorbable, Silk: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GAP
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAP
193in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAP
478in 2025
MAUDE reports naming product code GAP, 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 | 1 | — | 0 | 7 |
| 2008 | 1 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 21 | 6 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 2 | — | 0 | 54 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 1 | — | 1 | 340 |
| 2019 | 0 | — | 0 | 333 |
| 2020 | 0 | — | 0 | 426 |
| 2021 | 0 | — | 0 | 437 |
| 2022 | 0 | — | 0 | 419 |
| 2023 | 1 | — | 1 | 404 |
| 2024 | 3 | 193 | 0 | 455 |
| 2025 | 0 | — | 0 | 478 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160623: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160623
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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