Atlas FDA

SCALP DURA RETRACTOR, MODEL KS00474

FDA 510(k) clearance K093054 · decided 2010-11-15

Clearance details

K-number
K093054
Device name
SCALP DURA RETRACTOR, MODEL KS00474
Applicant
KARL STORZ Endoscopy-America, Inc.
Decision
Substantially Equivalent
Date received
2009-09-30
Decision date
2010-11-15
Days to decision
411 days
Clearance type
Traditional
Product code
GZT
Device class
2
Regulation number
882.4800
Medical specialty
Neurology
Advisory committee
Neurology
Location
El Segundo, CA, 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

RecordFirmDate
Photodynamic Diagnostic D-Light C System (P050027/S034)KARL STORZ Endoscopy-America, Inc.2025-10-01
KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033)KARL STORZ Endoscopy-America, Inc.2025-05-02
KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032)KARL STORZ Endoscopy-America, Inc.2024-09-27
KARL STORZ D-Light C PDD System (P050027/S031)KARL STORZ Endoscopy-America, Inc.2023-05-05
KARL STORZ D-Light C PDD System (P050027/S030)KARL STORZ Endoscopy-America, Inc.2022-03-17
KARL STORZ D-Light C PDD System (P050027/S028)KARL STORZ Endoscopy-America, Inc.2022-02-04
KARL STORZ D-Light C PDD System (P050027/S029)KARL STORZ Endoscopy-America, Inc.2021-10-13
D-Light C PDD System (P050027/S027)KARL STORZ Endoscopy-America, Inc.2021-01-08