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510(k) K910816

IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE by Insight International, Inc. — Product Code KDD

K910816 is an FDA 510(k) premarket notification submitted by Insight International, Inc. for the device "IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE". The FDA issued a decision of Substantially Equivalent (kit) on April 17, 1991. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Insight International, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 17, 1991
Date Received
February 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Insight International, Inc.

  • K862094 — LENS-EZE (June 19, 1986)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources