510(k) K131721
- Device
- EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
- Applicant
- COMED MEDICAL SYSTEMS CO., LTD
- 510(k) number
- K131721
- Product code
- LNS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-22
- Date received
- 2013-06-12
- Regulation
- 876.5990
- Classification name
- Lithotriptor, Extracorporeal Shock-wave, Urological
- 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
- J. HARVEY KNAUSS
- Address
- 11874 S. Evelyn Cir. Houston TX US 77071 77071
FDA Registration Numbers#
- 3029915542
- 3040388525
- 9611388
- 3005655081
- 1037955
- 3006066512
- 3002807616
- 1061158
- 9611102
- 9613347
- 3017140415
- 3005462245
- 9612448
- 3010202439
- 3014640847
- 3009212453
- 2020550
- 3004977335
Source Documents#
Other 510(k) Records For Product Code LNS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261086 | Break Wave | Sonomotion, Inc. | 2026-04-29 |
| K252913 | Break Wave | Sonomotion, Inc. | 2026-01-12 |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | 2023-02-22 |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | 2023-01-19 |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021-03-30 |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2020-09-03 |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2017-08-08 |
| K170122 | Delta III Lithotripter | Dornier Medtech America | 2017-06-28 |
| K151298 | Gemini XXP-HP | Dornier Medtech America | 2015-07-30 |
| K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015-03-20 |
| K131817 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech America | 2013-09-23 |
| K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech Systems | 2013-05-14 |
| K121656 | GEMINI LITHOTRIPTER | Dornier Medtech America, Inc. | 2012-09-24 |
Legacy Summary#
summary
FDA Review#
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