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510(k) K940911

BASICS ENDOSCOPY SYSTEM by Cox Medical Ent., Inc. — Product Code KGE

K940911 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "BASICS ENDOSCOPY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 16, 1994. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Cox Medical Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1994
Date Received
February 25, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Cox Medical Ent., Inc.

  • K950689 — UCB (March 6, 1995)
  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K941464 — BASICS ENDOSCOPY SYSTEM (August 5, 1994)
  • K932790 — THERMAL OPTION (January 28, 1994)
  • K935250 — ACCU-PATH (January 21, 1994)
  • K924655 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (December 15, 1992)
  • K923671 — COX DISPOSABLE POLYPECTOMY SNARES (October 13, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)
  • K914442 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (October 25, 1991)

Other clearances for product code KGE

  • K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (March 6, 2026)
  • K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (October 7, 2025)
  • K242857 — ClearHemograsper (May 21, 2025)
  • K231721 — Disposable Hot Biopsy Forceps (December 14, 2023)
  • K220053 — Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (February 4, 2022)
  • K210406 — Bipolar Coagulation Foreceps (October 5, 2021)
  • K202438 — Ensure Single-Use Coagulation Forceps (March 15, 2021)
  • K183428 — Avulsion Forceps (April 16, 2019)
  • K180018 — Disposable Hot Biopsy Forceps (July 5, 2018)
  • K180134 — Ensizor Monopolar Endoscopic Scissors (June 29, 2018)

FDA data resources