FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
K Number: K964334
·
Decision Dec 9, 1996
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
13
Review Days
39
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
- EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT)
- K Number
- K964334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shippert Medical Technologies Corp.
- Date Received
- October 31, 1996
- Decision Date
- December 9, 1996
- 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 Shippert Medical Technologies Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | Aug 6, 2010 | Substantially Equivalent |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | Dec 4, 2009 | Substantially Equivalent |
| K092022 | TISSU TRANS HARVEST TUBING | Aug 17, 2009 | Substantially Equivalent |
| K050797 | TISSU-TRANS | Jul 13, 2005 | Substantially Equivalent |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | Mar 4, 1997 | Substantially Equivalent |
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | Nov 26, 1996 | Substantially Equivalent |
| K962133 | EXPANDACELL INJECTO-PAK | Aug 1, 1996 | Substantially Equivalent |
| K960621 | EXPANDACELL INSTRUMENT WIPE | Apr 1, 1996 | Substantially Equivalent |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | Feb 27, 1996 | Substantially Equivalent |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | Dec 22, 1995 | Substantially Equivalent |