CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
FDA 510(k) clearance K150259 · decided 2015-11-06
Clearance details
- K-number
- K150259
- Device name
- CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
- Applicant
- Taiwan Surgical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-02-03
- Decision date
- 2015-11-06
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Zhubei City, TW
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Taiwan Surgical Corporation
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
No recalls on record reference this clearance.