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510(k) K190512

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare by Intelligent Endoscopy — Product Code FDI

K190512 is an FDA 510(k) premarket notification submitted by Intelligent Endoscopy for the device "SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2019
Date Received
March 1, 2019
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

Other clearances for product code FDI

  • K251692 — Advanced Tissue Resection Device (February 21, 2026)
  • K221713 — Polypectomy Snare (March 3, 2023)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K220089 — Disposable Polyp Snare (September 22, 2022)
  • K220790 — Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (June 27, 2022)
  • K213222 — Disposable Polypectomy Snare (June 6, 2022)
  • 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)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K191048 — AcuSnare Polypectomy Snare - Duckbill (July 18, 2019)

FDA data resources