Atlas FDA

RESECTOSCOPES

FDA 510(k) clearance K954050 · decided 1995-11-22

Clearance details

K-number
K954050
Device name
RESECTOSCOPES
Applicant
KARL STORZ Endoscopy-America, Inc.
Decision
Substantially Equivalent
Date received
1995-08-29
Decision date
1995-11-22
Days to decision
85 days
Clearance type
Traditional
Product code
FJL
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
KARL STORZ Monopolar Resectoscopes with HF Cable (K232486)Karl Storz SE & CO. KG2024-05-07
KARL STORZ Bipolar Resectoscopes with HF Cable (K221893)Karl Storz Endoscopy America, Inc.2023-03-17
Veloxion System (K230205)Corinth Medtech, Inc.2023-02-24
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (K191341)Corinth Medtech, Inc.2019-06-13
Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch (K190099)Corinth Medtech, Inc.2019-03-15
Veloxion System (K162979)Corinth Medtech, Inc.2017-03-24
AED RESECTOSCOPE (K102663)National Advanced Endoscopy Devices, Inc.2010-12-30
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES (K062720)Richard Wolf Medical Instruments Corp.2007-03-22
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES (K042523)Richard Wolf Medical Instruments Corp.2005-03-18
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 (K041610)Richard Wolf Medical Instruments Corp.2004-08-19
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE (K001270)Gyrus Medical , Ltd.2000-04-28
COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS (K971881)Comeg Endoscopy1997-08-12

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