FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGITEK(R) TURP MONITOR
K Number: K903127
·
Decision Oct 9, 1990
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
85
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
- SURGITEK(R) TURP MONITOR
- K Number
- K903127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Surgitek Medical Engineering Corp.
- Date Received
- July 16, 1990
- Decision Date
- October 9, 1990
- 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 Surgitek Medical Engineering Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914504 | CYTOLOGY BRUSH | Feb 18, 1992 | Substantially Equivalent |
| K914495 | E.R.C.P. CATHETER | Jan 30, 1992 | Substantially Equivalent |
| K914497 | BIOPSY FORCEPS | Jan 3, 1992 | Substantially Equivalent |
| K914505 | STONE BASKET | Dec 9, 1991 | Substantially Equivalent |
| K914496 | SCLEROTHERAPY NEEDLE | Dec 5, 1991 | Substantially Equivalent |
| K914503 | GRASPING FORCEPS | Dec 5, 1991 | Substantially Equivalent |
| K913928 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT | Nov 19, 1991 | Substantially Equivalent |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Oct 4, 1991 | Substantially Equivalent |
| K910769 | SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM | Jun 25, 1991 | Substantially Equivalent |
| K910768 | SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE | Mar 19, 1991 | Substantially Equivalent |