STRYKER T4 HYTREL (R) TOGAS
FDA 510(k) clearance K011755 · decided 2001-06-22
Clearance details
- K-number
- K011755
- Device name
- STRYKER T4 HYTREL (R) TOGAS
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-06
- Decision date
- 2001-06-22
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- LYU
- Device class
- 1
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NURSES BOUFFANT CAP (K965237) | Copioumed Intl., Inc. | 1997-08-27 |
| FAR-EAST BOUFFANT CAPS (K970988) | Far East Science & Technology Development Co., Ltd. | 1997-07-10 |
| DISPOSABLE APRON (K964364) | Instrument Makar, Inc. | 1997-02-25 |
| DEPUY DISPOSABLE FILTER/HOOD (K961791) | Depuy, Inc. | 1996-08-09 |
| AMMI MAGNI-GUARD (K961454) | American Medical Mfg., Inc. | 1996-07-25 |
| SLOAN STA-DRI PANT PROTECTOR (K945302) | Sloan Corp. | 1996-03-19 |
| ULTRAFIT LINERS (K954314) | Stahmer Weston Scientific | 1995-12-28 |
| I-SPOUSE (K953089) | Products For Medicine | 1995-10-16 |
| SPLASH ASSIST (K952303) | Innovative Outsourcing Solutions | 1995-08-24 |
| ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS (K942200) | Thantex Specialties, Inc. | 1995-08-07 |
| SLOAN STA-DRI BOOTLEG LEGGING (K944276) | Sloan Corp. | 1995-07-31 |
| SLOAN STA-DRI SURGICAL JUMPSUIT (K944118) | Sloan Corp. | 1995-07-31 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |