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510(k) K974775

SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE by Airtronic Services, Inc. — Product Code FAP

K974775 is an FDA 510(k) premarket notification submitted by Airtronic Services, Inc. for the device "SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE". The FDA issued a decision of Substantially Equivalent on February 19, 1998. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1998
Date Received
December 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances for product code FAP

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  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (August 27, 1996)
  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
  • K931179 — UROLAB SPECTRUM (November 18, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)
  • K924086 — NICKI, MODEL NUMBER USD-NK-UP1 (October 20, 1992)

FDA data resources