RADLITE TISSUE RETRACTOR SYSTEM
FDA 510(k) clearance K022989 · decided 2002-11-25
Clearance details
- K-number
- K022989
- Device name
- RADLITE TISSUE RETRACTOR SYSTEM
- Applicant
- Genzyme Biosurgery
- Decision
- Substantially Equivalent
- Date received
- 2002-09-09
- Decision date
- 2002-11-25
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- FSW
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fall River, MA, US
- Third-party review
- No
- Expedited review
- No
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| LM-300TWIN (K913135) | Leisegang Medical, Inc. | 1991-09-18 |
| MEDICAL DYNAMICS LIGHT SOURCE (K894319) | Medical Dynamics, Inc. | 1989-10-03 |
| ULTRA-LUX LIGHT SOURCE (K870898) | Medline Industries, Inc. | 1987-03-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PREVELLE SILK (P030032/S017) | Genzyme Biosurgery | 2014-09-05 |
| PREVELLE SILK (P030032/S016) | Genzyme Biosurgery | 2014-08-06 |
| PREVELLE SILK (P030032/S014) | Genzyme Biosurgery | 2012-05-03 |
| PREVELLE SILK (P030032/S013) | Genzyme Biosurgery | 2011-10-07 |
| HYLAFORM (HYLAN B GEL); PREVELLE SILK (P030032/S012) | Genzyme Biosurgery | 2011-07-18 |
| PREVELLE SILK (P030032/S010) | Genzyme Biosurgery | 2010-09-15 |
| HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL) (P030032/S008) | Genzyme Biosurgery | 2010-02-24 |
| PREVELLE SILK & HYLAN B GEL (P030032/S009) | Genzyme Biosurgery | 2009-10-09 |