510(k) · Cleared
Recalled · Class II · 2022ORISE Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · PLL Submucosal Injection Agent
Cleared on Sep 28, 2018 as substantially equivalent to K150852 (Cosmo Technologies, Ltd., 2015) after a 262-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 28, 2018
- Review
- 262 days
- Class
- Class II
- Product code
- PLL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935844 (1995). 10 ancestors in all, the oldest K934356 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 6 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 5 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 4 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 3 generations backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- 2 generations backK111495 Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011
- 1 generation backK150852 SIC 8000Cosmo Technologies, Ltd. · 2015
- This deviceK180068 ORISE GelBoston Scientific · 2018
- Descendant · cites it directly · 0 of its ownK260997 Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260997Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01)Endoclot Plus Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −6 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −5 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −4 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −3 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| −2 | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K | Wilson-Cook Medical, Inc. | 2011 | — |
| −1 | K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015 | — |
| 0 (this device) | K180068 | ORISE Gel | Boston Scientific | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K150852 | SIC 8000Summary page 4…PLL Common Name: Submucosal Injection Agent Classification: Class II 3. Predicate Device: Trade Name: SIC-8000 (Eleview™) 510(k) Number: K150852 Classification Name: Endoscope and Accessories Regulation Number: 876.1500 Product Code: PLL Common Name: Submucos… | 2015 |
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 |
|---|---|---|---|
| K260997 | Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2022 | Class II | Z-0224-2023 | Under Investigation by firm | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K260997 (Endoclot Plus Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K150852.
How does its category compare?
All PLL devicesPLL Submucosal Injection Agent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
This device 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 as stated in the FDA summary.
https://510kreport.com/device/K180068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180068: ORISE Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180068
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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