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510(k) K172734

Single Use Electrosurgical Snare SD-400 by Olympus Medical Systems Corp. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2017
Date Received
September 11, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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Other clearances for product code FDI

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  • K212860 — SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB- (October 7, 2021)
  • K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snare (October 8, 2020)
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