Home / 510(k) Clearances / K950689

510(k) K950689

UCB by Cox Medical Ent., Inc. — Product Code MNL

K950689 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "UCB". The FDA issued a decision of Substantially Equivalent on March 6, 1995. The device falls under product code MNL (Accessories, Cleaning Brushes, For Endoscope), a Class I device regulated under 21 CFR 876.1500. Cox Medical Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1995
Date Received
February 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Cleaning Brushes, For Endoscope
Device Class
Class I
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Cox Medical Ent., Inc.

  • K946360 — MODULAR BIOPSY FORCEP (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)
  • K923671 — COX DISPOSABLE POLYPECTOMY SNARES (October 13, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)
  • K914466 — COX DISPOSABLE CYTOLOGY BRUSHES (October 25, 1991)

Other clearances for product code MNL

  • K946293 — MILL-ROSE SCOPE CLEANING BRUSH (February 16, 1995)
  • K892218 — ENDO-SPONGE (May 31, 1989)
  • K874239 — CLEANING BRUSH (December 29, 1987)

FDA data resources