FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
K Number: K091962
·
Decision Sep 30, 2009
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
11
Applicant Total
43
Review Days
91
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
- POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
- K Number
- K091962
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumenis, Inc.
- Date Received
- July 1, 2009
- Decision Date
- September 30, 2009
- Product Code
- ODF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| ODF | Mini Endoscope, Gastroenterology-Urology | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODF), ordered by most recent decision date.
MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPYSCOPE ACCESS AND DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPYGLASS DIRECT VISULATION PROBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
5 STAR MEDICAL ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Lumenis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211979 | Lumenis Y&R Laser System | Jun 21, 2022 | Substantially Equivalent |
| K151109 | Lumenis Smart532 Laser System | Oct 30, 2015 | Substantially Equivalent |
| K130195 | SCANNING LASERLINK | Nov 1, 2013 | Substantially Equivalent |
| K111213 | VISION ONE LASER SYSTEM | Jul 25, 2011 | Substantially Equivalent |
| K100228 | VERSAPULSE MODEL P20 LASER SYSTEM | Feb 24, 2010 | Substantially Equivalent |
| K082809 | ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM | Dec 18, 2008 | Substantially Equivalent |
| K081704 | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS | Sep 11, 2008 | Substantially Equivalent |
| K053628 | LIGHTSHEER DUET LASER SYSTEM | Apr 7, 2006 | Substantially Equivalent |
| K060338 | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO | Mar 9, 2006 | Substantially Equivalent |
| K052526 | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES | Nov 15, 2005 | Substantially Equivalent |