510(k) K131803
- Device
- GUARDIAN URETHRAL SHEATH
- Applicant
- SOLACE THERAPEUTICS
- 510(k) number
- K131803
- Product code
- KNY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-20
- Date received
- 2013-06-19
- Regulation
- 876.5130
- Classification name
- Accessories, Catheter, G-u
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM GRUBER
- Address
- 135 Newbury St. Farmingham MA US 01701 01701
FDA Registration Numbers#
- 3010155661
- 9617594
- 1423537
- 2183744
- 1713468
- 2029275
- 2022435
- 3012322232
- 3006174295
- 2029015
- 1921846
- 3003790304
- 3016171914
- 9611590
- 3002807314
- 3016096097
- 9680787
- 1625425
- 3004111573
- 3010707607
- 3011050570
- 2027111
- 9610617
- 3010202439
- 2032112
- 2020550
- 3009051888
- 3005232773
- 3014342096
- 3006082230
- 2126666
- 1018233
- 3009763019
- 9681477
- 8010418
- 9612030
- 2032098
- 3003915875
Source Documents#
Other 510(k) Records For Product Code KNY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182144 | Bi-Flex Evo | Promepla Sam | 2018-09-07 |
| K162356 | Vesair Cystoscopic Sheath | Solace Therapeutics | 2017-03-02 |
| K140441 | BI-FLEX URETERAL ACCESS SHEATH | Promepla Sam | 2014-06-17 |
| K140562 | WIJAY EZ-VOID EXTERNAL CATHETER VALVE | Leomed, LLC | 2014-06-16 |
| K141252 | GUARDIAN URETHRAL SHEATH | Solace Therapeutics | 2014-06-09 |
| K123170 | VARI-PASS VARIABLE LENGTH ACCESS SHEATH | Olympus Surgical Technologies America | 2013-02-04 |
| K120160 | ROCAMED ROCAUS PLATINUM | Promepla Sam | 2012-05-14 |
| K112209 | PREFILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2011-09-08 |
| K090121 | PRE-FILLED CATHETER INFLATION SYRINGE | Avail Medical Products, Inc. | 2009-04-15 |
| K052298 | CYSTOGLIDE INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2006-12-12 |
| K062240 | CAREVENT | Chief Medical, LLC | 2006-10-16 |
| K052952 | CATHASSIST | Physician Technologies, Inc. | 2006-05-14 |
| K052134 | CYSTOGLIDE DILATING INTRODUCER SHEATH | Percutaneous Systems, Inc. | 2005-09-22 |
| K051593 | UROPASS URETERAL ACCESS SHEATH, MODEL 61224 | Acmi Corporation | 2005-09-02 |
| K042531 | UPDATED SLIP UROLOGY INTRODUCER SHEATH | Percutaneous Systems, Incorporated | 2005-02-01 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases