HOTIP HEMOSTATIC PROBE
FDA 510(k) clearance K843628 · decided 1985-11-12
Clearance details
- K-number
- K843628
- Device name
- HOTIP HEMOSTATIC PROBE
- Applicant
- Trimedyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-14
- Decision date
- 1985-11-12
- Days to decision
- 424 days
- Clearance type
- Traditional
- Product code
- LNK
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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| ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (K874253) | Minnesota Laser Corp. | 1988-07-12 |
| MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (K880256) | Sharplan Lasers, Inc. | 1988-04-14 |
| MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (K880193) | Sharplan Lasers, Inc. | 1988-04-14 |
| ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (K875039) | Surgilase, Inc. | 1988-04-13 |
| MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (K880171) | Cooper Lasersonics, Inc. | 1988-04-11 |
| MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (K871934) | Lasermatic, Inc. | 1988-03-25 |
| MODEL 5050 SURGILASER FOR UROLOGY USE (K871932) | Lasermatic, Inc. | 1988-03-25 |
| SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (K873892) | Laserguide | 1988-02-02 |
| KTP/532 LASER (K873330) | Laserscope | 1987-11-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S026) | Trimedyne, Inc. | 1994-03-17 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S016) | Trimedyne, Inc. | 1994-03-17 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S027) | Trimedyne, Inc. | 1994-03-01 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S015) | Trimedyne, Inc. | 1992-03-20 |
| SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S014) | Trimedyne, Inc. | 1992-01-29 |
| MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013) | Trimedyne, Inc. | 1991-08-20 |
| TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025) | Trimedyne, Inc. | 1991-02-25 |
| 2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER (P870043/S011) | Trimedyne, Inc. | 1990-11-14 |