510(k) · Cleared
ClearedDisposable Dual Action Tissue Closure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mirco-Tech (Nanjing) Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Mar 19, 2024 as substantially equivalent to K212748 (Micro-Tech (Nanjing) Co., Ltd., 2022) after a 116-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Mar 19, 2024
- Review
- 116 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963160 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 5 generations between
- 3 generations backK151802 Resolution ClipBoston Scientific Corporation · 2015
- 2 generations backK202333 Lockado Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2021
- 1 generation backK212748 Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. · 2022
- This deviceK233772 Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK250229 Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 8 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 7 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 6 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 5 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 4 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 3 generations backK151802 Resolution ClipBoston Scientific Corporation · 2015
- 2 generations backK202333 Lockado Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2021
- 1 generation backK212748 Disposable Dual Action Tissue ClipMicro-Tech (Nanjing) Co., Ltd. · 2022
- This deviceK233772 Disposable Dual Action Tissue Closure DeviceMirco-Tech (Nanjing) Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K250229Dual Action Tissue Closure DeviceMicro-Tech (Nanjing) Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −8 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −7 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −6 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −5 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −4 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −3 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| −2 | K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
| −1 | K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| 0 (this device) | K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024 | — |
| +1 | K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K212748 | Disposable Dual Action Tissue ClipSummary page 6…2 of 7 510(k) summary 4. Identification of Predicate Device 510(k) Number: K212748 Product Name: Disposable Dual Action Tissue Clip Manufacturer: Micro-Tech (Nanjing) Co., Ltd. 5. Indications for Use The… | 2022 |
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 |
|---|---|---|---|
| K250229 | Dual Action Tissue Closure Device | 2025 | 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?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K250229 (Micro-Tech (Nanjing) Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
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. 2024, 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 Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of
tissue in the gastrointestinal tract for adult patient only.
The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the
purpose of:
1. Endoscopic marking;
2. Hemostasis for:
a.Mucosal/sub-mucosal defects< 5 cm,
b.Bleeding ulcers,
c.Polyps< 1.5 cm in diameter,
d.Diverticula in the colon,
e.Arteries< 2 mm,
3. As a supplementary method, closure of GI tract luminal perforations< 20 mm that can be treated conservatively.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233772 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233772: Disposable Dual Action Tissue Closure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233772
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