FASCIA CUTTER
FDA 510(k) clearance K834514 · decided 1984-03-12
Clearance details
- K-number
- K834514
- Device name
- FASCIA CUTTER
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-21
- Decision date
- 1984-03-12
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- GES
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PERSONNA PLUS SAFETY SCALPEL SYSTEM (K032242) | Omi Manufacturing Pty., Ltd. | 2003-09-23 |
| EASY-ON (K932998) | Devon Industries, Inc. | 1993-08-18 |
| LOS ALAMOS RETRACTABLE KNIFE (K923170) | Innovative Surgical Technology, Inc. | 1993-02-18 |
| SCALPEL BLADE REMOVER (BLADEGARD) (K915119) | Intergrated Visual, Inc. | 1992-05-05 |
| PRECISION GLIDE - ENHANCED SURGICAL BLADE (K911913) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-13 |
| STERILE CARBON STEEL SURGICAL BLADE (K900266) | Rahn Laboratories | 1990-03-01 |
| ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE (K884862) | Anchor Products Co. | 1988-12-27 |
| SURGICAL BLADE (K881638) | Far East Intl. Trading Corp. | 1988-06-15 |
| SURGICAL BLADES (K880244) | Ailee C/O Havel'S, Inc. | 1988-02-10 |
| NINJA SCALPEL (K873493) | Primrose Medical, Inc. | 1987-09-24 |
| PERSONNA DISPOSABLE SCALPEL (K873142) | American Safety Razor Co. | 1987-09-04 |
| DEXTRA DISPOSABLE BLADES (K863867) | Storz Instrument Co. | 1986-10-24 |
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 |