FDA 510(k) K232460, Disposable electrosurgical pencil (MD1000), by Shenzhen Mecun Medical Supply Co., Ltd.
FDA 510(k) K232460, Disposable electrosurgical pencil (MD1000), by Shenzhen Mecun Medical Supply Co., Ltd.
FDA 510(k) records for Disposable electrosurgical pencil (MD1000) (K232460), submitted by Shenzhen Mecun Medical Supply Co., Ltd..
- 510(k) Number: K232460
- Device Classification: Electrosurgical, Cutting & Coagulation & Accessories
- Applicant: Shenzhen Mecun Medical Supply Co., Ltd.
- Date Received: 08/15/2023
- Decision Date: 10/11/2023
- Decision: Substantially Equivalent (SESE)
- Regulation Number: 878.44
- Product Code: GEI
- Regulation Medical Specialty: General & Plastic Surgery
- Review Panel: General & Plastic Surgery
- Total Pages: 635 (113 unredacted, 82% redacted overall)
What's in this document (sections may appear in any order):
- ~ 510(k) Summary / Statement: 57% redacted
- ✗ Indications for Use: 86% redacted
- ✗ Device Description: 92% redacted
- ✗ Substantial Equivalence / Predicate: 76% redacted
- ✗ Performance / Bench Testing: 90% redacted
- ✗ Biocompatibility: 100% redacted
- ✗ Software / Cybersecurity: 66% redacted
- ✗ Sterilization / Shelf Life: 75% redacted
- ✗ Labeling / IFU: 100% redacted
- ✗ Clinical Data: 100% redacted
- — FDA Correspondence: no distinct section found
- ✗ Risk Analysis / FMEA: 100% redacted
- ✗ Electromagnetic Compatibility (EMC): 95% redacted
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
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