OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
FDA 510(k) clearance K896821 · decided 1990-02-09
Clearance details
- K-number
- K896821
- Device name
- OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
- Applicant
- North American Sterilization & Packaging Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-04
- Decision date
- 1990-02-09
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- KOQ
- Device class
- 1
- Regulation number
- 872.3410
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sparta, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch North American Sterilization & Packaging Co.
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 |
|---|---|---|
| URESIL ENDOSCOPIC LASER OVERTUBE (K901882) | Uresil Corp. | 1990-07-27 |
| NAS&P GRASPING FORCEPS & ASSOC. DEVICES (K900401) | 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.