STS-T LITHOTRIPTER, MODEL STS-T
FDA 510(k) clearance K010900 · decided 2001-04-05
Clearance details
- K-number
- K010900
- Device name
- STS-T LITHOTRIPTER, MODEL STS-T
- Applicant
- Medstone Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-26
- Decision date
- 2001-04-05
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Break Wave (K261086) | Sonomotion, Inc. | 2026-04-29 |
| Break Wave (K252913) | Sonomotion, Inc. | 2026-01-12 |
| Extracorporeal Shock Wave Lithotripter (U200) (K242922) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| LM-9300 Plus Lithotripter (K213772) | Lite-Med, Inc. | 2023-01-19 |
| Modulith SLX-F2 (K201001) | Karl Storz Endoscopy America | 2021-03-30 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| Delta III Lithotripter (K172084) | Dornier Medtech America, Inc. | 2017-08-08 |
| Delta III Lithotripter (K170122) | Dornier Medtech America | 2017-06-28 |
| Gemini XXP-HP (K151298) | Dornier Medtech America | 2015-07-30 |
| LM-9300 ELMA Lithotripter (K142561) | Lite-Med, Inc. | 2015-03-20 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K131817) | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MEDSTONE STS-TC/U LITHOTRIPTER (P970042/S003) | Medstone Intl., Inc. | 2003-02-14 |
| MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (P970042/S004) | Medstone Intl., Inc. | 2003-01-28 |
| MEDSTONE STS LITHOTRIPTER (P970042/S002) | Medstone Intl., Inc. | 2002-08-20 |
| MEDSTONE STS LITHOTRIPTER (P970042/S001) | Medstone Intl., Inc. | 2001-02-05 |
| MEDSTONE STS LITHOTRIPTER (P970042) | Medstone Intl., Inc. | 2000-09-05 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S036) | Medstone Intl., Inc. | 2000-07-26 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S035) | Medstone Intl., Inc. | 2000-02-25 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S034) | Medstone Intl., Inc. | 1999-11-19 |