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510(k) K923671

COX DISPOSABLE POLYPECTOMY SNARES by Cox Medical Ent., Inc. — Product Code FDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1992
Date Received
July 22, 1992
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 Cox Medical Ent., Inc.

  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950689 — UCB (March 6, 1995)
  • K941464 — BASICS ENDOSCOPY SYSTEM (August 5, 1994)
  • K940911 — BASICS ENDOSCOPY SYSTEM (May 16, 1994)
  • K932790 — THERMAL OPTION (January 28, 1994)
  • K935250 — ACCU-PATH (January 21, 1994)
  • K924655 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (December 15, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)
  • K914466 — COX DISPOSABLE CYTOLOGY BRUSHES (October 25, 1991)

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  • 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)