510(k) · Cleared
ClearedSandShark Injectable Anchor (SIA) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stimwave Technologies, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Nov 7, 2019 as substantially equivalent to K172644 (Stimwave Technologies Incorporated, 2017) after a 157-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Nov 7, 2019
- Review
- 157 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930738 (1994). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 7 generations between
- 3 generations backK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
- 2 generations backK150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture…Anchor Innovation Medical (A.I.M.) · 2015
- 1 generation backK172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod…Stimwave Technologies Incorporated · 2017
- This deviceK191466 SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. · 2019
Show all 11 generations
- Root · 11 generations backK930738 Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcDeknatel, Inc. · 1994 · Recalled
- 10 generations backK021019 Cottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. · 2002 · Recalled
- 9 generations backK061386 Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc. · 2006
- 8 generations backK062307 Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc. · 2006
- 7 generations backK091432 Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc. · 2009
- 6 generations backK111462 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 5 generations backK112849 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 4 generations backK113400 Fixate Tissue BandAnulex Technologies, Inc. · 2011
- 3 generations backK113805 Fixate Tissue BandAnulex Technologies, Inc. · 2012
- 2 generations backK150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture…Anchor Innovation Medical (A.I.M.) · 2015
- 1 generation backK172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod…Stimwave Technologies Incorporated · 2017
- This deviceK191466 SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc | Deknatel, Inc. | 1994 | 9 |
| −10 | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester Suture | Genzyme Corp. | 2002 | 7 |
| −9 | K061386 | Anchor Band Suturing System, Model SR-AB | Anulex Technologies, Inc. | 2006 | — |
| −8 | K062307 | Xclose Tissue Repair System, Model SRS | Anulex Technologies, Inc. | 2006 | — |
| −7 | K091432 | Xclose Tissue Repair System, Model XC-200-01 | Anulex Technologies, Inc. | 2009 | — |
| −6 | K111462 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| −5 | K112849 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| −4 | K113400 | Fixate Tissue Band | Anulex Technologies, Inc. | 2011 | — |
| −3 | K113805 | Fixate Tissue Band | Anulex Technologies, Inc. | 2012 | — |
| −2 | K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter… | Anchor Innovation Medical (A.I.M.) | 2015 | — |
| −1 | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with… | Stimwave Technologies Incorporated | 2017 | — |
| 0 (this device) | K191466 | SandShark Injectable Anchor (SIA) System | Stimwave Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 GZB? 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 GZB device
- #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 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 |
|---|---|---|---|
| * | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…Summary page 4…GZB Device Class: Class II Classification Panel: Neurology 4. Legally Marketed Predicate Device(s) SandShark Injectable Anchor (SIA) System (K172644) 5. Device Description The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fi… | 2017 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 15 ancestors have a recall of any class.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, 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 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the
Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the stimulator to the fascia or interspinous/supra-
spinous ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191466: SandShark Injectable Anchor (SIA) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191466
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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