510(k) K183590
- Device
- Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip
- Applicant
- Olympus Medical Systems Corp.
- 510(k) number
- K183590
- Product code
- PKL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-08-01
- Date received
- 2018-12-21
- Regulation
- 876.4400
- Classification name
- Hemostatic Metal Clip For The Gi Tract
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Toshiyuki Nakajima
- Address
- 2951 Ishikawa-Cho Hachioji-Shi JP 192-8507 192-8507
FDA Registration Numbers#
- 3006621103
- 3014769442
- 3006696607
- 3030733800
- 3009217531
- 3010188783
- 1528319
- 3008720584
- 3010515547
- 3013440400
- 3017210488
- 3010273872
- 3013460719
- 3008797804
- 1047843
- 9611680
- 3013526170
- 3014620201
- 2183446
- 3012494290
- 3025311469
- 3033841914
- 3009747810
- 3012042439
- 3014328942
- 1000121056
- 3031276312
- 3035434483
- 3010288205
- 3015142721
- 3017178358
- 1056129
- 3013557562
- 9611283
- 3013023255
- 3044854047
- 3010432890
- 1061927
- 9614641
- 3004837686
- 8010047
- 2246552
- 3016696686
- 3005099803
- 3011050570
- 3011193403
- 9681260
- 3017390965
- 3021023752
- 3007695959
- 3030446844
- 3007829657
- 1037905
Source Documents#
Other 510(k) Records For Product Code PKL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | 2026-05-21 |
| K252270 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 |
| K253734 | Taurus Clip | Taurus Endoscopy | 2026-03-12 |
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025-12-18 |
| K252271 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 |
| K250229 | Dual Action Tissue Closure Device | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 |
| K250842 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2025-04-18 |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | Boston Scientific Corporation | 2025-02-06 |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 2025-01-02 |
| K240274 | PADLOCK CLIP EFTR Kit (00713229) | STERIS Corporation | 2024-09-17 |
| K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | 2024-08-26 |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 |
| K232969 | Disposable Hemostatic Clips | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-06-07 |
| K240617 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) | Olympus Medical Systems Corp. | 2024-06-03 |
| K233772 | Disposable Dual Action Tissue Closure Device | Mirco-Tech (Nanjing) Co., Ltd. | 2024-03-19 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases