COOK WIRE GUIDES— 510(k) K082536
Substantially EquivalentCook Urological, Inc.
FDA 510(k) clearance K082536 for COOK WIRE GUIDES, Substantially Equivalent on 2008-10-27. Applicant: Cook Urological, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook Urological, Inc.
- Product code
- Code OCY
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Spencer, IN, US
Recent devices under product code OCY
view all- K153264 — EasyPass Guidewire
- K151471 — Radifocus Glidewire Endoscopic Wire
- K150927 — Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff
- K150225 — NovaGold High Performance Guidewire
- K142950 — Acrobat Calibrated Tip Wire Guide
More clearances from Cook Urological, Inc.
view allAdverse events under product code OCY
product code OCY- Injury
- 186
- Malfunction
- 578
- Total
- 764
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 K082536
K-number listed on FDA's recall record- Z-1837-2022 — Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542
- Z-0959-2020 — Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
- Z-0960-2020 — Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285
- Z-0961-2020 — Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260
- Z-0962-2020 — PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
- Z-0963-2020 — Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
- Z-0964-2020 — Wire Guide, Guidewire, Global Product Number G14326
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082536.
Data sourced from openFDA. This site is unofficial and independent of the FDA.