510(k) · Cleared
ClearedSingle Use Hemoclip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Chuangxiang Medical Technology Co., Ltd. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Mar 20, 2018 as substantially equivalent to K152001 (Micro-Tech (Nanjing) Co., Ltd., 2015) and 1 other predicate after a 188-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Mar 20, 2018
- Review
- 188 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K963160 (1997). 1 later device descends from it, 1 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 backK152001 Sterile Repositionable Hemostasis Clipping DeviceMicro-Tech (Nanjing) Co., Ltd. · 2015
- 1 generation backK161463 SureClip (TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. · 2017
- This deviceK172762 Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK212669 Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K212669Single Use HemoclipZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · 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 | K152001 | Sterile Repositionable Hemostasis Clipping Device | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| −1 | K161463 | SureClip (TM) Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | 2017 | — |
| 0 (this device) | K172762 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018 | — |
| +1 | K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K152001 | Sterile Repositionable Hemostasis Clipping DeviceSummary page 4…fication name: Hemorrhoidal ligator Regulation class: 2 Regulation number:876.4400 Panel: Gastroenterology/Urology Product code: PKL 3. Predicate device 510(k) Number: K152001, Product Name: Sterile Repositionable Hemostasis Clipping Device 510(k) Number: K161463 Product Name: SureClipTM Repositionable… | 2015 |
| * | K161463 | SureClip (TM) Repositionable Hemostasis ClipSummary page 4…Gastroenterology/Urology Product code: PKL 3. Predicate device 510(k) Number: K152001, Product Name: Sterile Repositionable Hemostasis Clipping Device 510(k) Number: K161463 Product Name: SureClipTM Repositionable Hemostasis Clip 4. Device description The proposed device Single Use Hemoclip is a steri… | 2017 |
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 |
|---|---|---|---|
| K212669 | Single Use Hemoclip | 2022 | 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 21 years and passes through 6 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, K212669 (Zhejiang Chuangxiang Medical Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K152001.
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 Single Use Hemoclip device is indicated for endoscopic clip placement within the gastrointestinal tract 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,
(3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
(4) the age of the intended population for the device is for patients who are 18 and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172762: Single Use Hemoclip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172762
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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