AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES— 510(k) K090470
Substantially EquivalentCovidien
FDA 510(k) clearance K090470 for AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES, Substantially Equivalent on 2009-05-14. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code OCW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
Recent devices under product code OCW
view allMore clearances from Covidien
view all- K241486 — Sofsilk Coated Braided Silk Suture
- K240077 — Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)
- K231934 — GIA Stapler with Tri-Staple Technology
- K223130 — Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)
- K231491 — TA Stapler and Loading Unit with DST Series Technology
Adverse events under product code OCW
product code OCW- Death
- 6
- Injury
- 443
- Malfunction
- 1,023
- Other
- 2
- Total
- 1,474
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 →
Recalls naming K090470
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090470.
Data sourced from openFDA. This site is unofficial and independent of the FDA.