FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
K Number: K000545
·
Decision May 2, 2000
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
56
Review Days
74
Basic Information
- Device Name
- SENTRY EXPANDING INTRODUCER SHEATH (EIS)
- K Number
- K000545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- APPLIED MEDICAL RESOURCES
- Date Received
- February 18, 2000
- Decision Date
- May 2, 2000
- 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 APPLIED MEDICAL RESOURCES
| K Number | Device Name | ||
|---|---|---|---|
| K153017 | Voyant Fine Fusion | Jul 6, 2016 | Substantially Equivalent |
| K153288 | Voyant Open Fusion Device | Jun 1, 2016 | Substantially Equivalent |
| K151480 | Epix Electrosurgical Probe with Smoke Evacuation | Feb 19, 2016 | Substantially Equivalent |
| K143308 | GelPOINT Transvaginal Access Platform | Oct 13, 2015 | Substantially Equivalent |
| K143536 | Voyant Fine Fusion Device | Apr 16, 2015 | Substantially Equivalent |
| K143517 | Voyant Open Sealer-Divider Device | Mar 27, 2015 | Substantially Equivalent |
| K142427 | TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 | Dec 23, 2014 | Substantially Equivalent |
| K141288 | VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE | Aug 22, 2014 | Substantially Equivalent |
| K100959 | SPECIMEN RETRIEVAL SYSTEM | Apr 22, 2010 | Substantially Equivalent |
| K062907 | ALEXIS WOUND RETRACTOR | Jan 9, 2007 | Substantially Equivalent |