510(k) · Cleared
ClearedSureClip Repositionable Hemostasis Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Dec 14, 2018 as substantially equivalent to K151802 (Boston Scientific Corporation, 2015) after an 88-day review. Its family tree reaches back 7 generations to 1997. 6 later devices descend from it.
- Decided
- Dec 14, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963160 (1997). 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 6 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 5 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 4 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 3 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 2 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 1 generation backK151802 Resolution ClipBoston Scientific Corporation · 2015
- This deviceK182556 SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2018
- Descendant · cites it directly · 4 of its ownK193424 Resolution 360™ ULTRA ClipBoston Scientific Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK222503 Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipBoston Scientific Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK253734 Taurus ClipTaurus Endoscopy · 2026
- Descendant · 3 generations on · 0 of its ownK250066 Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution…Boston Scientific Corporation · 2025
- Descendant · cites it directly · 0 of its ownK222146 Disposable Endoscopic HemoclipJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K193424Resolution 360™ ULTRA ClipBoston Scientific Corporation · 2020 · cites it directly4descendants
- K222503Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA ClipBoston Scientific Corporation · 2022 · 2 generations on2descendants
- K253734Taurus ClipTaurus Endoscopy · 2026 · 3 generations on0descendants
- K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602)…Boston Scientific Corporation · 2025 · 3 generations on0descendants
- K222146Disposable Endoscopic HemoclipJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −6 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −5 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −4 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −3 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −2 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −1 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +1 | K193424 | Resolution 360™ ULTRA Clip | Boston Scientific Corporation | 2020 | — |
| +2 | K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | Boston Scientific Corporation | 2022 | — |
| +3 | K253734 | Taurus Clip | Taurus Endoscopy | 2026 | — |
| +3 | K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip… | Boston Scientific Corporation | 2025 | — |
| +1 | K222146 | Disposable Endoscopic Hemoclip | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 PKL? 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 PKL device
- #1 K202333 Lockado Repositionable Hemostasis Clipscore 17.5 · 7 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 |
|---|---|---|---|
| * | K151802 | Resolution ClipSummary page 5…f 5 510K Summary 4. Identification of Predicate Device Predicate Device 510(k) Number: K151802 Product Name: Resolution 360™ Clip Manufacturer: Boston Scientific Corporation Reference Device 510(k) Number: K152… | 2015 |
| † | K152001 | Sterile Repositionable Hemostasis Clipping Device | 2015 |
What descends from it? (6)
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)
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 21 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K193424 (Boston Scientific Corporation, 2020) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K151802.
How does its category compare?
All PKL devicesPKL Hemostatic Metal Clip For The Gi Tract: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PKL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKL
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKL
1,170in 2025
MAUDE reports naming product code PKL, 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 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | 102 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 3 | 143 | 0 | 34 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 2 | — | 0 | 398 |
| 2018 | 5 | 116 | 0 | 393 |
| 2019 | 4 | 231 | 1 | 699 |
| 2020 | 6 | 164 | 0 | 504 |
| 2021 | 2 | — | 0 | 668 |
| 2022 | 9 | 259 | 0 | 522 |
| 2023 | 2 | — | 0 | 863 |
| 2024 | 8 | 181 | 0 | 1,216 |
| 2025 | 6 | 162 | 0 | 1,170 |
| 2026 | 7 | 231 | 0 | — |
What is it indicated for?
The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of :
(1) Endoscopic marking;
(2) Hemostasis for
(a) Mucosal / sub-mucosal defects < 3cm,
(b) Bleeding ulcers,
(c) Polyps < 1.5cm in diameter,
(d) Diverticula in the colon,
(e) Arteries < 2 mm
(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182556: SureClip Repositionable Hemostasis Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182556
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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