510(k) · Cleared
ClearedSharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, Undyed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Jan 28, 2002 as substantially equivalent to K944110 (ETHICON, Inc., 1995) after a 53-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 28, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944110 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK944110 Vicryl Rapide SutureETHICON, Inc. · 1995 · Recalled
- This deviceK014021 Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture…Surgical Specialties Corp · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944110 | Vicryl Rapide Suture | ETHICON, Inc. | 1995 | 2 |
| 0 (this device) | K014021 | Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, Undyed | Surgical Specialties Corp | 2002 | — |
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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K944110 | Vicryl Rapide SutureSummary page 3…orbable surgical suture is similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110). The determination of substantial equivalence for this device was based on a detailed device description, physical testing (U.S… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 10 other devices also cite its predicate K944110.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
Sharpoint® Coated FastAbsbrbing‘“ PolyGlycolic Acid Suture is indicated only for use in superficial soft tissue approximation of the skin and mucosa where only short term wound support (7 — 10 days) is required. Coated Fast Absorbing™ PolyGlycolic Acid Suture is not intended for use in ligation, ophthalmic cardiovascular or neurological procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014021: Sharpoint Coated, Fast Absorbing Polyglycolic Acid Synthetic Suture, Undyed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014021
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026