FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFLECTABLE ELECTROSURGICAL PROBES
K Number: K991190
·
Decision Jun 23, 1999
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
24
Review Days
76
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
- DEFLECTABLE ELECTROSURGICAL PROBES
- K Number
- K991190
- 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
- Oratec Interventions, Inc.
- Date Received
- April 8, 1999
- Decision Date
- June 23, 1999
- 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 Oratec Interventions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013622 | NUCLEOTOMY INTRADISCAL CATHETER | Jan 31, 2002 | Substantially Equivalent |
| K003198 | VULCAN TAC PROBES, MODEL 911XXX | Aug 29, 2001 | Substantially Equivalent |
| K003893 | VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X | Mar 1, 2001 | Substantially Equivalent |
| K000691 | VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS | May 4, 2000 | Substantially Equivalent |
| K992805 | ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) | Feb 4, 2000 | Substantially Equivalent |
| K994333 | ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES | Jan 18, 2000 | Substantially Equivalent |
| K993967 | ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002 | Dec 17, 1999 | Substantially Equivalent |
| K993854 | ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES | Dec 6, 1999 | Substantially Equivalent |
| K991140 | ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES | Oct 25, 1999 | Substantially Equivalent |
| K991218 | ORATEC BIPOLAR ABLATION PROBES | Sep 13, 1999 | Substantially Equivalent |