FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MURDOCH LAPAROSCOPE LENS CLEANER
K Number: K941092
·
Decision Apr 11, 1994
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
190
Review Days
34
Basic Information
- Device Name
- MURDOCH LAPAROSCOPE LENS CLEANER
- K Number
- K941092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COOK, INC.
- Date Received
- March 8, 1994
- Decision Date
- April 11, 1994
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
Disposable Trocars
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8 mm Assist Cannula; 12 mm Assist Cannula
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Boehringer Laboratories Liver Retractor
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Medical Monitor (32HS710S)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Arthrex Synergy Vision Endoscopic Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LAGIS Suction Irrigation System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by COOK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | Jan 9, 2015 | Substantially Equivalent |
| K140593 | ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE | Dec 15, 2014 | Substantially Equivalent |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | Oct 9, 2014 | Substantially Equivalent |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | Apr 18, 2014 | Substantially Equivalent |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | Feb 20, 2014 | Substantially Equivalent |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | Jan 29, 2014 | Substantially Equivalent |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | Dec 23, 2013 | Substantially Equivalent |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | Oct 25, 2013 | Substantially Equivalent |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | Oct 7, 2013 | Substantially Equivalent |
| K131206 | COOK CERVICAL RIPENING BALLOON | Sep 27, 2013 | Substantially Equivalent |