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510(k) K894869

WILTEK POLYPECTOMY SNARE by Wiltek Medical, Inc. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1989
Date Received
July 31, 1989
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 by Wiltek Medical, Inc.

  • K990231 — WILTEK HOT BIOPSY FORCEPS (April 13, 1999)
  • K922989 — WILTEK IRRIGAITON/ASPIRATION TUBE SET (February 15, 1994)
  • K930419 — WILTEK BIOPSY FORCEPS (June 1, 1993)
  • K914881 — WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914882 — WILTEK BALLOON CHOLANGIOGRAPHY CATHETER (January 7, 1992)
  • K914131 — WILTEK ELECTROCAUTERY ADAPTOR (September 25, 1991)
  • K914132 — WILTEK ELECTROCAUTERY ACTIVE CORD (September 25, 1991)
  • K912288 — WILTEK STANDARD CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K912122 — CHOLANGIOGRAPHY CATHETER (September 23, 1991)
  • K910334 — ELECTROCAUTERY PROBE (February 21, 1991)

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)
  • K190512 — SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare (November 22, 2019)