510(k) · Cleared
ClearedSharpoint Ultraplug Extended Wear Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Specialties Corp · LZU Plug, Punctum
Cleared on Jul 26, 2002 as substantially equivalent to K003015 (Surgical Specialties Corp, 2000) after a 130-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 26, 2002
- Review
- 130 days
- Class
- Class U
- Product code
- LZU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003015 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK003015 Ssc's PCL Monofilament Sas, Violet, Coated, Model TBDSurgical Specialties Corp · 2000
- This deviceK020882 Sharpoint Ultraplug Extended Wear PlugSurgical Specialties Corp · 2002
- Descendant · cites it directly · 0 of its ownK053333 Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K053333Eaglevision Gellanserts, Model Ref 0040Eagle Vision, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003015 | Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD | Surgical Specialties Corp | 2000 | — |
| 0 (this device) | K020882 | Sharpoint Ultraplug Extended Wear Plug | Surgical Specialties Corp | 2002 | — |
| +1 | K053333 | Eaglevision Gellanserts, Model Ref 0040 | Eagle Vision, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 LZU? 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 LZU device
- #1 K241229 Hello,eyes® BIO Plugscore 8.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K003015 | Ssc's PCL Monofilament Sas, Violet, Coated, Model TBD | 2000 |
| * | — | Surgidev Silicone Punctum Plug Named without a submission number | |
| * | — | US IOL Inc, Occu-Flo Punctum Plug Named without a submission number | |
| * | — | Eagle Vision Temporary Intracanalicular Collagen Insert Named without a submission number | |
| * | — | Surgical Specialties Corporations (formerly Look, Inc.) Temporary Intracanalicular… Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053333 | Eaglevision Gellanserts, Model Ref 0040 | 2006 | 0 |
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?
How does its category compare?
All LZU devicesLZU Plug, Punctum: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZU
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZU
148in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZU
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZU
3in 2025
MAUDE reports naming product code LZU, 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 | 10 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 3 | 148 | 0 | 10 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Sharpoint® UltraPlug™ Extended Wear Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, UltraPlug™ Extended Wear Plugs may be used after ocular surgery to prevent complications due to dry eye and to enhance the retention of ocular medications. Patients experiencing dry eye related contact lens problems also may be aided by UltraPlug™ Extended Wear Plugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020882: Sharpoint Ultraplug Extended Wear Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020882
Report an extraction error
Are you the manufacturer?
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