CANDELA GUIDEWIRE
FDA 510(k) clearance K933268 · decided 1994-02-10
Clearance details
- K-number
- K933268
- Device name
- CANDELA GUIDEWIRE
- Applicant
- Candela Laser Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-06
- Decision date
- 1994-02-10
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- NWU
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayland, MA, 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 |
|---|---|---|
| PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (K874045) | American Pharmaseal Div. Ahsc | 1987-12-03 |
| BRISTOL BALLON INTRODUCER, MANDRIL SET (K813332) | Inmed Corp. | 1981-12-14 |
Recalls involving this device
No recalls on record reference this clearance.