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510(k) K931398

GM SWIVEL VIDEO (TM) IRRIGATOR by Gm Engineering, Inc. — Product Code KAR

K931398 is an FDA 510(k) premarket notification submitted by Gm Engineering, Inc. for the device "GM SWIVEL VIDEO (TM) IRRIGATOR". The FDA issued a decision of Substantially Equivalent on August 30, 1993. The device falls under product code KAR (Irrigator, Sinus), a Class I device regulated under 21 CFR 874.4420. Gm Engineering, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1993
Date Received
March 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irrigator, Sinus
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Gm Engineering, Inc.

  • K953348 — ARTICULATING RETRACTOR TISSUE RETRACTORS (September 12, 1995)
  • K942626 — CONTINUOUS FLOW BIOPSY PROBE (May 30, 1995)
  • K932394 — BERNSTEIN(TM) UTERINE MANIPULATOR (January 26, 1995)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K942703 — GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CAN (August 19, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K941660 — GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT (May 24, 1994)
  • K933962 — GM CONTINUOUS FLOW BIOPSY PROBE (February 25, 1994)
  • K930611 — TRUE FLOW(TM) VALVE (December 1, 1993)
  • K934035 — GM MONOPOLAR/FRAZIER SUCTION PROBE (December 1, 1993)

Other clearances for product code KAR

  • K131177 — SINUFLUSH LAVAGE SYSTEM (September 20, 2013)
  • K861298 — FISCH DRILL IRRIGATOR (April 23, 1986)

FDA data resources