Atlas FDA

KSEA VASCULAR FIBERSCOPES

FDA 510(k) clearance K001408 · decided 2000-10-30

Clearance details

K-number
K001408
Device name
KSEA VASCULAR FIBERSCOPES
Applicant
KARL STORZ Endoscopy-America, Inc.
Decision
Substantially Equivalent
Date received
2000-05-04
Decision date
2000-10-30
Days to decision
179 days
Clearance type
Traditional
Product code
LYK
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Culver City, CA, 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.

RecordFirmDate
Vena MicroAngioscope™ System (K253842)Vena Medical Holdings Corp2026-01-28
Vena MicroAngioscope™ System (K251767)Vena Medical Holdings Corp2025-10-01
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM (K062340)Cardio-Optics, Inc.2006-11-30
CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 (K050808)Cardio-Optics, Inc.2005-07-28
KSEA FIBERSCOPE (K011793)KARL STORZ Endoscopy-America, Inc.2002-04-17
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 (K012724)Smith & Nephew, Inc.2001-11-08
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) (K964061)W. L. Gore & Associates, Inc.1997-02-20
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ (K952638)Baxter Edwards1995-07-28
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE (K951721)Applied Medical Resources1995-07-11
APPLIED MEDICAL OPTICAL VALVULOTOME (K945591)Applied Medical Resources1995-02-10
ULTATHIN FLEXIBLE ENDOSCOPE (K941715)Technology Marketing Group1994-10-04
ANGIOSCOPE (K934696)Intramed Laboratories, Inc.1994-01-18

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