FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC RETRACTORS
K Number: K092684
·
Decision Jan 22, 2010
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
26
Review Days
143
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Basic Information
- Device Name
- LAPAROSCOPIC RETRACTORS
- K Number
- K092684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardinal Health, Inc.
- Date Received
- September 1, 2009
- Decision Date
- January 22, 2010
- 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 |
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| K122696 | POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) | Jan 31, 2013 | Substantially Equivalent |
| K121897 | PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES | Jul 27, 2012 | Substantially Equivalent |
| K120934 | PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS | May 23, 2012 | Substantially Equivalent |
| K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | Sep 29, 2011 | Substantially Equivalent |
| K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | Jun 8, 2011 | Substantially Equivalent |
| K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | May 6, 2011 | Substantially Equivalent |