FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMCATH DISPOSABLE MICRO SCISSORS
K Number: K912605
·
Decision Jul 11, 1991
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
17
Review Days
29
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
- AMCATH DISPOSABLE MICRO SCISSORS
- K Number
- K912605
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intl. Medical, Inc.
- Date Received
- June 12, 1991
- Decision Date
- July 11, 1991
- 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.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Intl. Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970507 | PEAK FLOW METER | Jun 13, 1997 | Substantially Equivalent |
| K943078 | HOT BIOPSY FORCEPS | Nov 14, 1994 | Substantially Equivalent |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | Aug 17, 1994 | Substantially Equivalent |
| K940335 | AMERICAN CATHETER POLY-SNARE | Jul 21, 1994 | Substantially Equivalent |
| K942068 | AMERICAN CATHETER SPHINCTEROTOME | Jun 24, 1994 | Substantially Equivalent |
| K930406 | DURHAM; MIN BORE LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K930410 | DURHAM; LUER LOCK EXTENSION SET | Sep 3, 1993 | Substantially Equivalent |
| K923200 | AMCATH DISPOSABLE CYTOLOGY BRUSH | Dec 7, 1992 | Substantially Equivalent |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Jan 10, 1992 | Substantially Equivalent |
| K912927 | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE | Sep 19, 1991 | Substantially Equivalent |