FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC UMBRELLA RETRACTOR
K Number: K930462
·
Decision Jul 22, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
28
Review Days
175
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
- ENDOSCOPIC UMBRELLA RETRACTOR
- K Number
- K930462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgical Technologies, Inc.
- Date Received
- January 28, 1993
- Decision Date
- July 22, 1993
- 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 Surgical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941992 | CYSTOSCOPE | Nov 30, 1995 | Substantially Equivalent |
| K942029 | ARTHROSCOPE | Nov 8, 1995 | Substantially Equivalent |
| K946136 | INFINITECH LIGHTED INFUSION CANNULA | Oct 2, 1995 | Substantially Equivalent |
| K952566 | OSCILFLATOR | Aug 31, 1995 | Substantially Equivalent |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Jul 20, 1995 | Substantially Equivalent |
| K950683 | ARTHROGRAM TRAY | May 6, 1995 | Substantially Equivalent |
| K946135 | INFINITECH ASPIRATING LASER PROBE | Apr 18, 1995 | Substantially Equivalent |
| K946181 | INFINITECH SOFT TIP FLUTE NEEDLE | Mar 14, 1995 | Substantially Equivalent |
| K942030 | BIOPSY SCISSORS | Jun 27, 1994 | Substantially Equivalent |
| K942482 | PRESSURE MONITORING EXTENSION | Jun 14, 1994 | Substantially Equivalent |