510(k) · Cleared
ClearedCypris eXact Suturing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cypris Medical · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Jan 12, 2024 as substantially equivalent to K131224 (Surgical Specialties Corp. Dba Angiotech, 2013) and 2 other predicates after a 105-day review. Its family tree reaches back 12 generations to 2002.
- Decided
- Jan 12, 2024
- Review
- 105 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K014153 (2002). 44 ancestors in all, the oldest K885018 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations between
- 3 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 2 generations backK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- 1 generation backK131224 Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical…Surgical Specialties Corp. Dba Angiotech · 2013
- This deviceK233355 Cypris eXact Suturing SystemCypris Medical · 2024
Show all 12 generations
- Root · 12 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 11 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 10 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 9 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 8 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 7 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 6 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 5 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 4 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 3 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 2 generations backK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- 1 generation backK131224 Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical…Surgical Specialties Corp. Dba Angiotech · 2013
- This deviceK233355 Cypris eXact Suturing SystemCypris Medical · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −11 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −10 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −9 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −8 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −7 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −6 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −5 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| −4 | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | 1 |
| −3 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| −2 | K130078 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| −1 | K131224 | Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture… | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| 0 (this device) | K233355 | Cypris eXact Suturing System | Cypris Medical | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K131224 | Sharpoint Polypropylene Surgical Suture, Look Polypropylene Surgical Suture, Quill…Summary page 6…Number Predicate Sharpoint Polypropylene Surgical Suture, LOOK Polypropylene K131224 Surgical Suture, Quill Polypropylene Knotless Tissue-Closure / Surgical Specialties Corp.… | 2013 |
| * | K160744 | LOOK PTFE SutureSummary page 6…e K131224 Surgical Suture, Quill Polypropylene Knotless Tissue-Closure / Surgical Specialties Corp. LOOK PTFE Suture K160744 / Surgical Specialties Corp. Sharpoint PDO (polydioxanone) Sutures K063680 / Surgica… | 2016 |
| * | K063680 | Sharpoint Pdo (Polydioxanone) SuturesSummary page 6…/ Surgical Specialties Corp. LOOK PTFE Suture K160744 / Surgical Specialties Corp. Sharpoint PDO (polydioxanone) Sutures K063680 / Surgical Specialties Corp. The predicate devices have not been subject to a design related recall. DEVICE DESCR… | 2007 |
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?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 14 of the 44 ancestors have a recall of any class.
- 1 other device also cites its predicate K131224.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
Cypris eXact Suture PP (Polypropylene) The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Cypris eXact Suture PTFE (Polytetraflouroethylene) The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. Cypris eXact Suture PDO (Polydioxanone)…
Read the full statement (118 words)
Cypris eXact Suture PP (Polypropylene)
The Cypris eXact Suture (PP) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Cypris eXact Suture PTFE (Polytetraflouroethylene)
The Cypris eXact Suture (PTFE) is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
Cypris eXact Suture PDO (Polydioxanone)
The Cypris eXact Suture (PDO) is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Cypris eXact 5.1 Suture Placement Device can be used in conjunction with eXact Sutures, which are indicated for use in general soft tissue approximation and/or ligation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233355: Cypris eXact Suturing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233355
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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