FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE
K Number: K912611
·
Decision Apr 15, 1992
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
11
Review Days
308
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
- OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE
- K Number
- K912611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olsen Electrosurgical, Inc.
- Date Received
- June 12, 1991
- Decision Date
- April 15, 1992
- 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 Olsen Electrosurgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922154 | INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION | Apr 21, 1994 | Substantially Equivalent |
| K913108 | TEFLON COATED ELECTRODES/ELECTRODES HANDLES | Dec 23, 1991 | Substantially Equivalent |
| K912612 | SMOKE/ODOR EVACUATOR #757 | Nov 1, 1991 | Substantially Equivalent |
| K885200 | 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE | Jan 13, 1989 | Substantially Equivalent |
| K885199 | #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES | Jan 13, 1989 | Substantially Equivalent |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Oct 24, 1988 | Substantially Equivalent |
| K884173 | #920 DISPOSABLE TUR CABLE | Oct 24, 1988 | Substantially Equivalent |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Oct 24, 1988 | Substantially Equivalent |
| K884175 | #820/821 BIPOLAR FORCEPS | Oct 24, 1988 | Substantially Equivalent |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Oct 24, 1988 | Substantially Equivalent |