MEDILASE SERIES 2100 ENDOSCOPE
FDA 510(k) clearance K900894 · decided 1990-06-22
Clearance details
- K-number
- K900894
- Device name
- MEDILASE SERIES 2100 ENDOSCOPE
- Applicant
- Medical Laser, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-27
- Decision date
- 1990-06-22
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- GCQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medical Laser
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) (K920979) | Codman & Shurtleff, Inc. | 1993-03-23 |
| CODMAN FLEXIBLE ENDOSCOPE (K871978) | Codman & Shurtleff, Inc. | 1987-08-25 |
| TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. (K864960) | Cooper Lasersonics, Inc. | 1987-02-10 |
| VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE (K860771) | Van-Tec, Inc. | 1986-04-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MLI 1000 ND:YAG OP LASER (P830025/S002) | Medical Laser, Inc. | 1985-09-06 |
| MEDITEC OPL3 ND:YAG LASER (P830025/S001) | Medical Laser, Inc. | 1985-06-25 |
| MEDITEC OPL3 ND:YAG LASER (P830025) | Medical Laser, Inc. | 1985-01-14 |