Atlas FDA

BRONCHO-FIBERSCOPE

FDA 510(k) clearance K832010 · decided 1983-08-01

Clearance details

K-number
K832010
Device name
BRONCHO-FIBERSCOPE
Applicant
KARL STORZ Endoscopy-America, Inc.
Decision
Substantially Equivalent
Date received
1983-06-23
Decision date
1983-08-01
Days to decision
39 days
Clearance type
Traditional
Product code
EOQ
Device class
2
Regulation number
874.4680
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examina recall (Z-0527-2014)Karl Storz Endoscopy America Inc2013-12-17

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