OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
FDA 510(k) clearance K073207 · decided 2008-05-08
Clearance details
- K-number
- K073207
- Device name
- OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167
- Applicant
- Celon AG Medical Instruments
- Decision
- Substantially Equivalent
- Date received
- 2007-11-13
- Decision date
- 2008-05-08
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Celon AG Medical Instruments
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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjun recall (Z-0747-2012) | Olympus America Inc. | 2012-01-13 |