CLIP PLUS Disposable Clip Applier,ML; CLIP PLUS Disposable Clip Applier,L— 510(k) K150259
Substantially EquivalentTaiwan Surgical Corporation
FDA 510(k) clearance K150259 for CLIP PLUS Disposable Clip Applier,ML; CLIP PLUS Disposable Clip Applier,L, Substantially Equivalent on 2015-11-06. Applicant: Taiwan Surgical Corporation. Device class: 2.
Clearance details
- Device name as filed
- CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
- Applicant
- Taiwan Surgical Corporation
- Product code
- Code FZP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhubei City, TW
Recent devices under product code FZP
view allMore clearances from Taiwan Surgical Corporation
view all- K252535 — Inno-Switch Laparoscopic Instruments
- K252532 — Inno-Port Disposable Bladed Trocar
- K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
- K202994 — InnoClip Disposable Clip Applier, InnoClip Clip Applier
- K150253 — Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm
Adverse events under product code FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.