FRAY BIO-PUNCH
FDA 510(k) clearance K921822 · decided 1992-10-28
Clearance details
- K-number
- K921822
- Device name
- FRAY BIO-PUNCH
- Applicant
- Fray Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-16
- Decision date
- 1992-10-28
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- MDM
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tonawanda, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. recall (Z-1654-2013) | Clorox Healthcare Holdings, LLC (dba HealthLink) | 2013-07-02 |
| PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biop recall (Z-1655-2013) | Clorox Healthcare Holdings, LLC (dba HealthLink) | 2013-07-02 |
| ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy. recall (Z-1656-2013) | Clorox Healthcare Holdings, LLC (dba HealthLink) | 2013-07-02 |