FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CoolSeal Generator® (CSL-200-90)
K Number: K253634
·
Decision Jun 17, 2026
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
116
Review Days
210
Basic Information
- Device Name
- CoolSeal Generator® (CSL-200-90)
- K Number
- K253634
- 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
- Hologic, Inc.
- Date Received
- November 19, 2025
- Decision Date
- June 17, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Hologic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Sep 25, 2025 | Substantially Equivalent |
| K243341 | Genius AI Detection 2.0 | Jul 31, 2025 | Substantially Equivalent |
| K243396 | Aptima SARS-CoV-2 Assay | Feb 13, 2025 | Substantially Equivalent |
| K243935 | Aptima CMV Quant Assay | Jan 17, 2025 | Substantially Equivalent |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | Nov 25, 2024 | Substantially Equivalent |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Nov 15, 2024 | Substantially Equivalent |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) | Jul 25, 2024 | Substantially Equivalent |
| K233352 | Aptima HCV Quant Dx Assay | Jul 24, 2024 | Substantially Equivalent |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | Jul 18, 2024 | Substantially Equivalent |
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Jan 31, 2024 | Unknown |