Atlas FDA

BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE

FDA 510(k) clearance K933715 · decided 1993-11-22

Clearance details

K-number
K933715
Device name
BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
1993-07-30
Decision date
1993-11-22
Days to decision
115 days
Clearance type
Traditional
Product code
GEX
Device class
2
Regulation number
878.4810
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Watertown, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Precision Spinal Cord Stimulator (SCS) Systems (P030017/S397)Boston Scientific Corp2026-07-10
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