URESIL ENDOSCOPIC LASER OVERTUBE
FDA 510(k) clearance K901882 · decided 1990-07-27
Clearance details
- K-number
- K901882
- Device name
- URESIL ENDOSCOPIC LASER OVERTUBE
- Applicant
- Uresil Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-26
- Decision date
- 1990-07-27
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- KOQ
- Device class
- 1
- Regulation number
- 872.3410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Skokie, IL, 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 |
|---|---|---|
| NAS&P GRASPING FORCEPS & ASSOC. DEVICES (K900401) | North American Sterilization & Packaging Co. | 1990-02-09 |
| OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE (K896821) | North American Sterilization & Packaging Co. | 1990-02-09 |
| DENTOLOCK DENTURE ADHESIVE CREAM (K831265) | Solar Dental Co., Inc. | 1983-05-09 |
Recalls involving this device
No recalls on record reference this clearance.