FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BI-POLAR FORCEPS
K Number: K854864
·
Decision Dec 24, 1985
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
27
Review Days
19
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
- BI-POLAR FORCEPS
- K Number
- K854864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Birtcher Corp.
- Date Received
- December 5, 1985
- Decision Date
- December 24, 1985
- 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 Birtcher Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K881328 | MODEL 375 ECG | May 18, 1988 | Substantially Equivalent |
| K860718 | ELECTROSURGERY PENCIL, MODEL 767 | Mar 24, 1986 | Substantially Equivalent |
| K860687 | BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768 | Mar 24, 1986 | Substantially Equivalent |
| K854814 | SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33 | Jan 13, 1986 | Substantially Equivalent |
| K850668 | ELECTROSURGICAL UNIT 774 | May 20, 1985 | Substantially Equivalent |
| K850943 | MODEL 775 BIPOLAR COAGULATOR | May 20, 1985 | Substantially Equivalent |
| K844101 | CARDIO-NEC MODEL 365 | Apr 9, 1985 | Substantially Equivalent |
| K844104 | CARDIO ANALYZER MODEL 380 | Mar 6, 1985 | Substantially Equivalent |
| K850297 | ELECTROSURGICAL PENCIL HOLDER 720 | Feb 28, 1985 | Substantially Equivalent |
| K844103 | CARDIOPAC DEFIBRILLATOR 444 | Jan 18, 1985 | Substantially Equivalent |