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510(k) K760522

TABLE, UROSURGICAL by Mallinckrodt Group, Inc. — Product Code KQS

K760522 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "TABLE, UROSURGICAL". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code KQS (Table, Cystometric, Non-Electric And Accessories), a Class I device regulated under 21 CFR 876.4890. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
August 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type

Other clearances by Mallinckrodt Group, Inc.

  • K945053 — LF CT HIG PRESSURE CATHETERS (May 19, 1995)
  • K945140 — URO-FLO (March 8, 1995)
  • K943581 — HYDRADJUST IV UROLOGICAL TABLE (January 4, 1995)
  • K943122 — SURGICAL DRAPES (September 7, 1994)
  • K934664 — HYDRAGOWN (May 24, 1994)
  • K920742 — HYDRAJUST IV UROLOGICAL TABLE (April 27, 1992)
  • K912944 — CT 8000 DIGITAL INJECTION SYSTEM (February 4, 1992)
  • K913264 — HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE (November 1, 1991)
  • K905789 — FRANKLIN 9000 WALL STAND (May 20, 1991)
  • K904147 — HUGH YOUNG II UROLOGICAL X-RAY SYSTEM (December 13, 1990)

Other clearances for product code KQS

  • K955019 — UROTRACT I (December 6, 1995)
  • K872022 — UROVIEW (July 16, 1987)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K860040 — HYDRAJUST III UROLOGICAL TABLE (February 10, 1986)
  • K852127 — AMSCO URO-ENDO MOBILE TABLE (August 8, 1985)
  • K801723 — UR 150-UR 150T (August 13, 1980)
  • K791699 — HYDRADJUST II UROLOGICAL TABLE (October 22, 1979)

FDA data resources