FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GYRUS ACMI HALO PKS CUTTING FORCEPS
K Number: K100896
·
Decision Jun 17, 2010
Classifications
1
FEI Numbers
839
Registration Numbers
839
Same Product Code
2251
Applicant Total
26
Review Days
78
Basic Information
- Device Name
- GYRUS ACMI HALO PKS CUTTING FORCEPS
- K Number
- K100896
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GYRUS ACMI, INC.
- Date Received
- March 31, 2010
- Decision Date
- June 17, 2010
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by GYRUS ACMI, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K161038 | PK Morcellator | Oct 7, 2016 | Substantially Equivalent |
| K152531 | InstaClear Lens Cleaner | Jan 15, 2016 | Substantially Equivalent |
| K142759 | PK Cutting Forceps for ESG-400 Workstation | Jan 13, 2015 | Substantially Equivalent |
| K142154 | PK NEEDLE | Dec 19, 2014 | Substantially Equivalent |
| K132383 | GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER | Feb 4, 2014 | Substantially Equivalent |
| K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) | Apr 5, 2013 | Substantially Equivalent |
| K122605 | PKS BILL | Dec 5, 2012 | Substantially Equivalent |
| K121678 | DTAD | Aug 30, 2012 | Substantially Equivalent |
| K120474 | GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY | Jul 10, 2012 | Substantially Equivalent |
| K120567 | GYRUS AMCI PK BUTTON ELECTRODE | Jun 20, 2012 | Substantially Equivalent |