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510(k) K933371

IMC ENDOSCOPIC INSTRUMENT HOLDER by Inman Medical Corp. — Product Code GCS

K933371 is an FDA 510(k) premarket notification submitted by Inman Medical Corp. for the device "IMC ENDOSCOPIC INSTRUMENT HOLDER". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Inman Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
July 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Battery-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Inman Medical Corp.

  • K933171 — INMAN IRRIGATION TAPERED PROBE (April 29, 1994)
  • K933169 — INMAN ENDOSCOPIC BLUNT DISSECTOR (April 19, 1994)
  • K933094 — INSUFFLATOR TUBING KIT W/FILTER (April 18, 1994)
  • K933382 — IMC CABLE/WIRE COVER (January 27, 1994)
  • K933774 — IMC SALINE WET DRESSING (November 8, 1993)
  • K933305 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE (October 5, 1993)
  • K933306 — IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (October 5, 1993)
  • K933170 — INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (September 16, 1993)
  • K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 31, 1993)
  • K921291 — INMAN MEDICAL PACKING STRIP (January 21, 1993)

Other clearances for product code GCS

  • K944062 — LAPRASCOPIC GRASPER (February 23, 1995)
  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K933201 — AESCULAP TROCAR INSTRUMENT SET (September 13, 1993)
  • K932762 — 10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT (August 31, 1993)
  • K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (July 2, 1993)
  • K931340 — GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR (July 1, 1993)
  • K925276 — M.I.S. TROCAR-CANNULA (May 24, 1993)
  • K921006 — LAPAROSCOPIC RETRACTOR SYSTEM (July 28, 1992)

FDA data resources