Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
FDA 510(k) clearance K242370 · decided 2024-12-19
Clearance details
- K-number
- K242370
- Device name
- Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
- Applicant
- Medline Industries, LP
- Decision
- Substantially Equivalent
- Date received
- 2024-08-09
- Decision date
- 2024-12-19
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Northfiled, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.