Codman Disposable Perforators— 510(k) K183581
Substantially EquivalentIntegra Lifesciences Corp.
FDA 510(k) clearance K183581 for Codman Disposable Perforators, Substantially Equivalent on 2019-01-20. Applicant: Integra Lifesciences Corp.. Device class: 2.
Clearance details
- Applicant
- Integra Lifesciences Corp.
- Product code
- Code HBF
- Device class
- Class 2
- Regulation
- 21 CFR 882.4305
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mansfield, MA, US
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- K182265 — CodMan Certas Plus Programmable Valve
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Adverse events under product code HBF
product code HBF- Injury
- 587
- Malfunction
- 621
- Other
- 1
- Total
- 1,209
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 K183581
K-number listed on FDA's recall record- Z-0373-2026 — CODMAN Disposable Perforator 11mm. Cranial Perforator.
- Z-0374-2026 — CODMAN Disposable Perforator 9mm. Cranial Perforator.
- Z-1716-2025 — CODMAN Disposable Perforator, 14mm. Cranial perforator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183581.
Data sourced from openFDA. This site is unofficial and independent of the FDA.