Atlas FDA

RESECTOSCOPE SHEATH

FDA 510(k) clearance K931995 · decided 1993-07-23

Clearance details

K-number
K931995
Device name
RESECTOSCOPE SHEATH
Applicant
Olympus Corp.
Decision
Substantially Equivalent
Date received
1993-04-23
Decision date
1993-07-23
Days to decision
91 days
Clearance type
Traditional
Product code
FJL
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Lake Success, NY, US
Third-party review
No
Expedited review
No

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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

RecordFirmDate
Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and trea recall (Z-1438-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection shea recall (Z-1439-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheat recall (Z-1440-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applicat recall (Z-1441-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection recall (Z-1442-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applica recall (Z-1443-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection s recall (Z-1444-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applica recall (Z-1445-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection s recall (Z-1446-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urologica recall (Z-1447-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological appl recall (Z-1448-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecologi recall (Z-1450-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecologi recall (Z-1451-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. recall (Z-1452-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in ur recall (Z-1453-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urologica recall (Z-1455-2026)Olympus Corporation of the Americas2026-02-20
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urologica recall (Z-1456-2026)Olympus Corporation of the Americas2026-02-20
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urol recall (Z-1457-2026)Olympus Corporation of the Americas2026-02-20