LASER OPTICAL CATHETER SYSTEM
FDA 510(k) clearance K880991 · decided 1988-05-25
Clearance details
- K-number
- K880991
- Device name
- LASER OPTICAL CATHETER SYSTEM
- Applicant
- Medline Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-08
- Decision date
- 1988-05-25
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HHR
- Device class
- 2
- Regulation number
- 884.4550
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Englewood, CO, 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 |
|---|---|---|
| ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (K881507) | Hgm Medical Laser Systems, Inc. | 1989-04-27 |
| MODEL 5050 SURGILASER FOR OB-GYN USE (K871875) | Lasermatic, Inc. | 1988-08-22 |
| GL-35 COLPOSCOPIC LASER SYSTEM (K875314) | Laser Engineering, Inc. | 1988-08-05 |
| LASER CANNISTER FILTER (K874615) | Medical Marketing, Inc. | 1988-06-23 |
| LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (K880591) | Laser Peripherals, LLC | 1988-06-01 |
| MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (K880930) | Copper Lasersonics, Inc. | 1988-05-31 |
| MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (K880173) | Cooper Lasersonics, Inc. | 1988-03-24 |
| KTP/532 LASER FOR OB-GYN USE (K874837) | Laserscope | 1988-03-14 |
| HERACURE LS 500 (K875078) | W.C. Heraeus GmbH | 1988-02-22 |
| MODEL 20-C, RL-20A/U, OB-10A/U (K872709) | Directed Energy, Inc. | 1988-02-02 |
| MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (K870841) | Directed Energy, Inc. | 1988-02-02 |
| ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE (K864946) | Bio Quantum Technologies, Inc. | 1988-01-28 |
Recalls involving this device
No recalls on record reference this clearance.