FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
K Number: K252487
·
Decision Mar 2, 2026
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
42
Review Days
207
Basic Information
- Device Name
- POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K Number
- K252487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gyrus Acmi, Inc.
- Date Received
- August 7, 2025
- Decision Date
- March 2, 2026
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Jun 3, 2021 | Substantially Equivalent |
| K181696 | ChitoZolve | Nov 30, 2018 | Substantially Equivalent |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter | Mar 8, 2018 | Substantially Equivalent |
| K170908 | PK AIM | May 19, 2017 | Substantially Equivalent |
| K163373 | PK AIM | Dec 12, 2016 | Substantially Equivalent |