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510(k) K926218

EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) by Sandhill Scientific, Inc. — Product Code HIR

K926218 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE)". The FDA issued a decision of Substantially Equivalent on August 26, 1994. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1994
Date Received
December 10, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Sandhill Scientific, Inc.

  • K111013 — ACEM (December 19, 2011)
  • 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)

Other clearances for product code HIR

  • K252748 — Pelvic Floor Exerciser (PF01) (April 27, 2026)
  • K240805 — Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) (August 1, 2024)
  • K231875 — Vaginal Tactile Ultrasound Imager (February 22, 2024)
  • K233362 — Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) (December 29, 2023)
  • K231780 — Perifit Care+ (December 20, 2023)
  • K221476 — Perifit (February 10, 2023)
  • K213913 — leva Pelvic Health System (June 30, 2022)
  • K212655 — Flyte (September 21, 2021)
  • K212495 — Leva Pelvic Health System (September 8, 2021)
  • K210764 — Flyte (April 13, 2021)

FDA data resources