510(k) · Cleared
ClearedSIC 8000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmo Technologies, Ltd. · PLL Submucosal Injection Agent
Cleared on Sep 3, 2015 as substantially equivalent to K111495 (Wilson-Cook Medical, Inc., 2011) after a 156-day review. Its family tree reaches back 6 generations to 1995. 8 later devices descend from it.
- Decided
- Sep 3, 2015
- Review
- 156 days
- Class
- Class II
- Product code
- PLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K935844 (1995). 9 ancestors in all, the oldest K934356 (1994). 8 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 5 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 4 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 3 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 2 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 1 generation backK111495 Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011
- This deviceK150852 SIC 8000Cosmo Technologies, Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK220434 Blue Eye (TS-905)The Standard Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK191923 EverLift Submucosal Lifting AgentGi Supply · 2020
- Descendant · cites it directly · 1 of its ownK191254 EndoClotEndoclot Plus Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK180068 ORISE GelBoston Scientific · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK260997 Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K220434Blue Eye (TS-905)The Standard Co., Ltd. · 2022 · cites it directly1descendant
- K191923EverLift Submucosal Lifting AgentGi Supply · 2020 · cites it directly1descendant
- K191254EndoClotEndoclot Plus Co., Ltd. · 2020 · cites it directly1descendant
- K180068ORISE GelBoston Scientific · 2018 · cites it directly1descendant
- K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −5 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −4 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −3 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −2 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −1 | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K | Wilson-Cook Medical, Inc. | 2011 | — |
| 0 (this device) | K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015 | — |
| +1 | K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | 2022 | — |
| +1 | K191923 | EverLift Submucosal Lifting Agent | Gi Supply | 2020 | — |
| +1 | K191254 | EndoClot | Endoclot Plus Co., Ltd. | 2020 | — |
| +1 | K180068 | ORISE Gel | Boston Scientific | 2018 | 1 |
| +2 | K260997 | Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) | Endoclot Plus Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 PLL? 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 PLL device
- #1 K260997 Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)score 14.1 · 8 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 |
|---|---|---|---|
| * | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KSummary page 6…bstantially equivalent in terms of both intended use and technological characteristics to the Cook GI Endoscopic Injection Gel Kit, which was cleared for marketing under K111495 on 19 July 2011 for sub mucosal lift of polyps or other gastrointestinal mucosal lesions, prior to excision with a snare or endos… | 2011 |
What descends from it? (8)
5 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)
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 20 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K220434 (The Standard Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PLL devicesPLL Submucosal Injection Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PLL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PLL
280in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLL
3in 2024
MAUDE reports naming product code PLL, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 4 | 280 | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 36 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150852: SIC 8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150852
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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