Atlas FDA

BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)

FDA 510(k) clearance K232951 · decided 2023-10-20

Clearance details

K-number
K232951
Device name
BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
Applicant
Steris
Decision
Substantially Equivalent
Date received
2023-09-21
Decision date
2023-10-20
Days to decision
29 days
Clearance type
Special
Product code
ODC
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mentor, OH, 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
DYNE PORT (K252933)Dyne Medical Group, Inc.2026-06-12
Biopsy Port Adapter (K250145)Endosound, Inc.2025-10-17
Orca Air/Water and Suction Valves (K252910)Boston Scientific2025-10-09
Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (K250949)Olympus Medical Systems Corporation2025-07-16
Disposable Endoscopy Valve Set (K250732)Yangzhou Fartley Medical Instrument Technology Co., Ltd.2025-06-20
Luer-Split MAJ-2092 (K241842)Olympus Medical Systems Corporation2025-03-19
Defendo Fujifilm 700 Single Use Cleaning Adapter (K250140)Steris Corparation2025-02-20
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (K243075)STERIS Corporation2024-11-08
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K242742)STERIS Corporation2024-10-11
Disposable Endoscope Valves Set (AF series) (K241285)Alton (Shanghai) Medical Instruments Co., Ltd.2024-10-01
Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector (K232067)Medivators (A Subsidiary of Steris Corporation)2024-03-22
Endorail (K232327)Endostart S.R.L.2024-03-15

Recalls involving this device

No recalls on record reference this clearance.