FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
K Number: K001593
·
Decision Jun 14, 2000
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
22
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
- K Number
- K001593
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chester Labs, Inc.
- Date Received
- May 23, 2000
- Decision Date
- June 14, 2000
- 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
CoolSeal Generator® (CSL-200-90)
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
Other Clearances by Chester Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041060 | E-Z LUBRICATING JELLY | May 7, 2004 | Substantially Equivalent |
| K001705 | STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF | Jun 29, 2000 | Substantially Equivalent |
| K944599 | GRAHAM-FIELD CONDUCTIVE ECG SPRAY | May 7, 1996 | Substantially Equivalent |
| K944598 | GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL | May 7, 1996 | Substantially Equivalent |
| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | Nov 20, 1995 | Substantially Equivalent |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | Jun 21, 1995 | Substantially Equivalent |
| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | Jun 7, 1995 | Substantially Equivalent |
| K940254 | BIOSHIELD BLUE POWDER FREE GLOVE | Mar 23, 1994 | Substantially Equivalent |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | Mar 23, 1994 | Substantially Equivalent |
| K841871 | LIQUA-SONIC GEL | Mar 14, 1985 | Substantially Equivalent |