VARI-PASS VARIABLE LENGTH ACCESS SHEATH
FDA 510(k) clearance K123170 · decided 2013-02-04
Clearance details
- K-number
- K123170
- Device name
- VARI-PASS VARIABLE LENGTH ACCESS SHEATH
- Applicant
- Olympus Surgical Technologies America
- Decision
- Substantially Equivalent
- Date received
- 2012-10-09
- Decision date
- 2013-02-04
- Days to decision
- 118 days
- Clearance type
- Special
- Product code
- KNY
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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| GUARDIAN URETHRAL SHEATH (K141252) | Solace Therapeutics | 2014-06-09 |
| GUARDIAN URETHRAL SHEATH (K131803) | Solace Therapeutics | 2013-08-20 |
| ROCAMED ROCAUS PLATINUM (K120160) | Promepla Sam | 2012-05-14 |
| PREFILLED CATHETER INFLATION SYRINGE (K112209) | Avail Medical Products, Inc. | 2011-09-08 |
| PRE-FILLED CATHETER INFLATION SYRINGE (K090121) | Avail Medical Products, Inc. | 2009-04-15 |
| CYSTOGLIDE INTRODUCER SHEATH (K052298) | Percutaneous Systems, Incorporated | 2006-12-12 |
| CAREVENT (K062240) | Chief Medical, LLC | 2006-10-16 |
Recalls involving this device
No recalls on record reference this clearance.