Home / 510(k) Clearances / K896205

510(k) K896205

MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE by Dexide, Inc. — Product Code GCI

K896205 is an FDA 510(k) premarket notification submitted by Dexide, Inc. for the device "MONOSCOPY BRAND, 5 MM LOCKING TROCAR SLEEVE". The FDA issued a decision of Substantially Equivalent on March 22, 1990. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Dexide, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1990
Date Received
October 26, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by Dexide, Inc.

  • K991814 — MULTACHOICE INSTRUMENTS (June 23, 1999)
  • K990379 — MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES (March 4, 1999)
  • K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES (September 25, 1998)
  • K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIES (July 29, 1998)
  • K953611 — DEXIDE ENDO-LUBE KIT (September 15, 1995)
  • K944509 — DEXIDE INSUFFLATION TUBING WITH FILTER (February 7, 1995)
  • K924117 — DEXIDE LAPAROSCOPIC KITS (March 23, 1993)
  • K923845 — DEXIDE LAPAROSCOPIC ACCESSORIES (November 25, 1992)
  • K921709 — ENDOBAG, MODIFICATION (July 14, 1992)
  • K913762 — MONOSCOPY(TM) BRAND, ENDOBAG (October 28, 1991)

Other clearances for product code GCI

  • K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR (August 15, 2002)
  • K003222 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER (November 3, 2000)
  • K001362 — KARL STORZ 3D VIDEO SYSTEM (July 17, 2000)
  • K933515 — BOOTY ENDOSCOPE WARMER (October 27, 1993)
  • K930302 — BIRTCHER SURE CLEAN INSTRUMENT SYSTEM (October 27, 1993)
  • K930496 — GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS (April 20, 1993)
  • K922123 — AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH (February 1, 1993)
  • K920139 — GLEESON CLOT-BUSTER (April 15, 1992)
  • K915762 — POOLE TIP SUCTION PROBE (March 13, 1992)
  • K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT (October 30, 1991)

FDA data resources