510(k) · Cleared
Recalled · 2003Surgical Spears
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultracell Medical Technologies, Inc. · HOZ Sponge, Ophthalmic
Cleared on Mar 19, 1993 after a 226-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 19, 1993
- Review
- 226 days
- Class
- Class II
- Product code
- HOZ
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK923922 Surgical SpearsUltracell Medical Technologies, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK972693 Deroyal Industries, Inc. Surgical Eye SpearDeroyal Industries, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK130117 Network Eye Spears, Points, Drains, Wicks and ShieldsNetwork Medical Products, Ltd. · 2013
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 |
|---|---|---|---|---|---|
| 0 (this device) | K923922 | Surgical Spears | Ultracell Medical Technologies, Inc. | 1993 | — |
| +1 | K972693 | Deroyal Industries, Inc. Surgical Eye Spear | Deroyal Industries, Inc. | 1997 | — |
| +1 | K130117 | Network Eye Spears, Points, Drains, Wicks and Shields | Network Medical Products, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HOZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2003 | Not classified | Z-0488-03 | Other | Sterility of the device is compromised |
| Jan 8, 2003 | Not classified | Z-0489-03 | Other | Sterility of the device is compromised |
| Jan 8, 2003 | Not classified | Z-0487-03 | Other | Sterility of the device is compromised |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972693 (Deroyal Industries, Inc., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HOZ devicesHOZ Sponge, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOZ
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · HOZ
Too few HOZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HOZ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HOZ
3in 2025
MAUDE reports naming product code HOZ, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 3 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K923922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923922: Surgical Spears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923922
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026