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510(k) K111013

ACEM by Sandhill Scientific, Inc. — Product Code FFZ

K111013 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "ACEM". The FDA issued a decision of Substantially Equivalent on December 19, 2011. The device falls under product code FFZ (Cord, Electric, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2011
Date Received
April 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Electric, For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Sandhill Scientific, Inc.

  • K012232 — INSIGHT, MODEL S980000 (June 7, 2002)
  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002427 — SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (June 22, 2001)
  • K990441 — INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (May 12, 1999)
  • K984444 — INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 (January 11, 1999)
  • K961056 — BIOVIEW MODEL S960000 (June 6, 1996)
  • K942247 — SMALL BOWEL ANALYSIS SOFTWARE (April 9, 1996)
  • K941801 — ANALGRAPH (September 8, 1995)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)
  • K926218 — EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) (August 26, 1994)

Other clearances for product code FFZ

  • K822254 — ELECTRIC CORD FOR ENDOSCOPE (August 20, 1982)
  • K782046 — C-CORD (January 10, 1979)

FDA data resources