FDA Product Code
FDA Product Code LNS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5990
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261086 | Break Wave | Sonomotion, Inc. | 2026-04-29 | Special | PDF ↗ |
| K252913 | Break Wave | Sonomotion, Inc. | 2026-01-12 | Traditional | PDF ↗ |
| K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 | Traditional | PDF ↗ |
| K221903 | Delta III Pro | Dornier Medtech America, Inc. | 2023-02-22 | Traditional | PDF ↗ |
| K213772 | LM-9300 Plus Lithotripter | Lite-Med, Inc. | 2023-01-19 | Traditional | PDF ↗ |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021-03-30 | Traditional | PDF ↗ |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2020-09-03 | Traditional | PDF ↗ |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | 2017-08-08 | Special | PDF ↗ |
| K170122 | Delta III Lithotripter | Dornier Medtech America | 2017-06-28 | Traditional | PDF ↗ |
| K151298 | Gemini XXP-HP | Dornier Medtech America | 2015-07-30 | Traditional | PDF ↗ |
| K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015-03-20 | Abbreviated | PDF ↗ |
| K131817 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 | Traditional | PDF ↗ |
| K131721 | EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 | Comed Medical Systems Co., Ltd. | 2014-07-22 | Traditional | PDF ↗ |
| K132672 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech America | 2013-09-23 | Special | PDF ↗ |
| K130729 | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER | Dornier Medtech Systems | 2013-05-14 | Special | PDF ↗ |
| K121656 | GEMINI LITHOTRIPTER | Dornier Medtech America, Inc. | 2012-09-24 | Special | PDF ↗ |
| K120769 | MODULTH SLK | KARL STORZ Endoscopy-America, Inc. | 2012-06-12 | Special | PDF ↗ |
| K111947 | DUET MAGNA | Direx Systems Corp. | 2012-03-01 | Traditional | PDF ↗ |
| K103217 | LITE-MED LM-9200 ELMA | Lite-Med, Inc. | 2011-09-28 | Abbreviated | PDF ↗ |
| K111808 | SONOLITH I-MOVE | Edap Tms France | 2011-08-01 | Traditional | PDF ↗ |
| K101482 | EM-9000 | Elite Medical, Inc. | 2011-03-31 | Traditional | PDF ↗ |
| K083614 | SONOLITH I-SYS LITHOTRIPER | Technomed Medical Systems, SA | 2009-07-27 | Abbreviated | PDF ↗ |
| K072538 | PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER | United Medical Systems, Inc. | 2008-01-30 | Traditional | PDF ↗ |
| K070665 | LITHOSKOP | Siemens Medical Solutions USA, Inc. | 2008-01-04 | Traditional | PDF ↗ |
| K072788 | STORZ MODULITH LITHOTRIPTER SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007-12-26 | Traditional | PDF ↗ |
| K070799 | MODULARIS VARIOSTAR | Siemens Medical Solutions USA, Inc. | 2007-11-01 | Traditional | PDF ↗ |
| K070579 | STORZ SLX-F2 STORM TOUCH | KARL STORZ Endoscopy-America, Inc. | 2007-08-30 | Special | PDF ↗ |
| K063504 | ECONOLITH EM1000 | Medispec, Ltd. | 2007-03-09 | Traditional | PDF ↗ |
| K061350 | LITHODIAMOND ULTRA | Pck Electronic Industry & Trade Co., Ltd. | 2006-12-22 | Traditional | PDF ↗ |
| K062081 | LITHOGOLD | Tissue Regeneration Technologies, Inc. | 2006-11-02 | Traditional | PDF ↗ |
| K062147 | INTEGRA SL | Direx Systems Corp. | 2006-10-20 | Special | PDF ↗ |
| K053640 | INTEGRA | Direx Systems Corp. | 2006-03-01 | Traditional | PDF ↗ |
| K050091 | TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) | Direx Systems Corp. | 2005-03-16 | Special | PDF ↗ |
| K042427 | GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Genemed, Inc. | 2004-12-03 | Special | PDF ↗ |
| K042561 | TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Fmd, LLC | 2004-10-12 | Special | PDF ↗ |
| K040476 | STORZ MODULITH, MODEL SLX-F2 | KARL STORZ Endoscopy-America, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K040741 | ULTRASOUND LOCALIZATION SYSTEM ULS 0142 | Hmt High Medical Technologies AG | 2004-08-19 | Traditional | PDF ↗ |
| K041582 | MODIFICATION TO TRIPTER X-1 COMPACT DUET | Direx Systems Corp. | 2004-07-07 | Special | PDF ↗ |
| K040461 | ECONOLITH E3000, MODEL 3000 (SW-6) | Medispec, Ltd. | 2004-05-25 | Special | PDF ↗ |
| K040470 | TRIPTER X-1 COMPACT | Direx Systems Corp. | 2004-04-28 | Special | PDF ↗ |
| K032958 | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 | United Medical Systems, Inc. | 2004-02-17 | Traditional | PDF ↗ |
| K030346 | TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER | Fmd, LLC | 2003-05-02 | Traditional | PDF ↗ |
| K023535 | TRIPTER X-1 COMPACT DUET | Direx Systems Corp. | 2003-01-17 | Special | PDF ↗ |
| K021775 | LTFS230 | Healthtronics, Inc. | 2002-12-23 | Traditional | PDF ↗ |
| K011700 | MODULITH SLK LITHOTRIPTER | Karl Storz Endoscopy | 2002-08-16 | Traditional | PDF ↗ |
| K013471 | DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER | E.S.W.L. Products, Inc. | 2002-04-29 | Traditional | PDF ↗ |
| K011106 | STONELITH, MODEL V5 | Pck Electronic Industry and Trade Co, Ltd. | 2002-02-11 | Traditional | PDF ↗ |
| K012785 | TWINTRODE ELC 134 ELECTRODE | Healthtronics Surgical Services, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K012482 | STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION | KARL STORZ Endoscopy-America, Inc. | 2001-10-16 | Traditional | PDF ↗ |
| K011873 | DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) | Dornier | 2001-08-31 | Traditional | PDF ↗ |
| K011773 | DORNIER LITHOTRIPTER 140(DOLI 140) | Dornier | 2001-06-22 | Special | PDF ↗ |
| K002801 | MPS M ELECTRODE | Medical Physics and Services, Inc. | 2001-05-04 | Traditional | PDF ↗ |
| K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER | Dornier Medtech America, Inc. | 2001-04-17 | Traditional | PDF ↗ |
| K010900 | STS-T LITHOTRIPTER, MODEL STS-T | Medstone Intl., Inc. | 2001-04-05 | Special | PDF ↗ |
| K010340 | MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI | Karl Storz Lithotripsy-America, Inc. | 2001-02-13 | Traditional | PDF ↗ |
| K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS | Edap Technomed, Inc. | 2001-02-12 | Abbreviated | PDF ↗ |
Product code LNS · Class II · Gastroenterology, Urology. Data: openFDA.