FRAY BIO-PUNCH— 510(k) K921822
Substantially EquivalentFray Products Corp.
FDA 510(k) clearance K921822 for FRAY BIO-PUNCH, Substantially Equivalent on 1992-10-28. Applicant: Fray Products Corp.. Device class: 1.
Clearance details
- Applicant
- Fray Products Corp.
- Product code
- Code MDM
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tonawanda, NY, US
Recent devices under product code MDM
view allAdverse events under product code MDM
product code MDM- Injury
- 247
- Malfunction
- 1,516
- Total
- 1,763
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 K921822
K-number listed on FDA's recall record- Z-1654-2013 — HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
- Z-1655-2013 — PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
- Z-1656-2013 — ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K921822.
Data sourced from openFDA. This site is unofficial and independent of the FDA.