TWINTRODE ELC 134 ELECTRODE
FDA 510(k) clearance K012785 · decided 2001-11-16
Clearance details
- K-number
- K012785
- Device name
- TWINTRODE ELC 134 ELECTRODE
- Applicant
- Healthtronics Surgical Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-20
- Decision date
- 2001-11-16
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| LITHOTRON ULS (P970019/S006) | Healthtronics Surgical Services, Inc. | 1999-12-17 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S003) | Healthtronics Surgical Services, Inc. | 1998-11-18 |
| LITHO TRON LITHOTRIPSY SYSTEM (P970019/S005) | Healthtronics Surgical Services, Inc. | 1998-11-17 |
| LITHOTRON ULTRA LITHOSTRIPSY SYSTEM (P970019/S004) | Healthtronics Surgical Services, Inc. | 1998-09-11 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S002) | Healthtronics Surgical Services, Inc. | 1998-07-14 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019/S001) | Healthtronics Surgical Services, Inc. | 1997-11-10 |
| HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM (P970019) | Healthtronics Surgical Services, Inc. | 1997-07-21 |