510(k) · Cleared
Recalled · Class II · 2015Sureflex and Accuflex Laser Lithotripsy Fibers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovaquartz · GEX Powered Laser Surgical Instrument
Cleared on Mar 14, 2005 after a 55-day review. The FDA summary names no predicate by number. 39 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 14, 2005
- Review
- 55 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 6
- Predicates
- 0
39 later devices descend from it, 7 citing it directly.
- This deviceK050108 Sureflex and Accuflex Laser Lithotripsy FibersInnovaquartz · 2005
- Descendant · cites it directly · 24 of its ownK120926 Endobeam Holmium Laser FibersC.R. Bard, Inc. · 2012
- Descendant · cites it directly · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK142638 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex…Innovaquartz, LLC · 2014
- Descendant · 2 generations on · 13 of its ownK170366 Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017
- Descendant · cites it directly · 6 of its ownK082928 Straight Fire Holmium Laser FiberBoston Scientific Corp · 2008
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K120926Endobeam Holmium Laser FibersC.R. Bard, Inc. · 2012 · cites it directly24descendants
- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · cites it directly23descendants
- K142638ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)Innovaquartz, LLC · 2014 · cites it directly15descendants
- K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC · 2017 · 2 generations on13descendants
- K082928Straight Fire Holmium Laser FiberBoston Scientific Corp · 2008 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050108 | Sureflex and Accuflex Laser Lithotripsy Fibers | Innovaquartz | 2005 | — |
| +1 | K120926 | Endobeam Holmium Laser Fibers | C.R. Bard, Inc. | 2012 | — |
| +1 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
| +1 | K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | Innovaquartz, LLC | 2014 | — |
| +2 | K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Laser Peripherals, LLC | 2017 | — |
| +1 | K082928 | Straight Fire Holmium Laser Fiber | Boston Scientific Corp | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (39)
See all 397 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120926 | Endobeam Holmium Laser Fibers | 2012 | 24 |
| K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and… | 2013 | 23 |
| K142638 | ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) | 2014 | 15 |
| K082928 | Straight Fire Holmium Laser Fiber | 2008 | 6 |
| K131473 | (Quanta System) Surgical Laser Fibers | 2013 | 5 |
| K121938 | Medilas H Rfid Laser Fiber | 2012 | 3 |
| K140679 | Sureflex Lithotripsy Laser Fibers | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2015 | Class II | Z-2161-2015 | Reprocessing Controls | validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new… |
| May 28, 2015 | Class II | Z-2159-2015 | Reprocessing Controls | validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new… |
| May 28, 2015 | Class II | Z-2157-2015 | Reprocessing Controls | validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new… |
| May 28, 2015 | Class II | Z-2160-2015 | Reprocessing Controls | validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new… |
| May 28, 2015 | Class II | Z-2156-2015 | Reprocessing Controls | validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new… |
| May 28, 2015 | Class II | Z-2158-2015 | Reprocessing Controls | validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K120926 (C.R. Bard, Inc., 2012) has gone furthest, with 24 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
General SureFlexTM and AccuFlexTM are intended for use in laser-based surgical applications, including but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, abaltion, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. While designed primarily for holmium (Ho:YAG)…
Read the full statement (105 words)
General
SureFlexTM and AccuFlexTM are intended for use in laser-based surgical applications, including but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, abaltion, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
While designed primarily for holmium (Ho:YAG) lasers, SureFlex TM and AccuFlexTM fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd:YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050108 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050108: Sureflex and Accuflex Laser Lithotripsy Fibers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050108
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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