FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3 FRENCH FLEXIBLE BIOPSY FORCEPS
K Number: K881399
·
Decision Apr 11, 1988
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
104
Review Days
7
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
- 3 FRENCH FLEXIBLE BIOPSY FORCEPS
- K Number
- K881399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cook Urological, Inc.
- Date Received
- April 4, 1988
- Decision Date
- April 11, 1988
- Product Code
- OCZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OCZ), ordered by most recent decision date.
KARL STORZ Endoscopic Accessories for Urology
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Grasping Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Grasping Forceps
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ensizor Endoscopic Scissors
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENSIZOR ENDOSCOPIC SCISSORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cook Urological, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | May 6, 2011 | Substantially Equivalent |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Oct 9, 2009 | Substantially Equivalent |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Sep 3, 2009 | Substantially Equivalent |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Nov 7, 2008 | Substantially Equivalent |
| K082536 | COOK WIRE GUIDES | Oct 27, 2008 | Substantially Equivalent |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Sep 25, 2008 | Substantially Equivalent |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Apr 17, 2008 | Substantially Equivalent |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |