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510(k) K863725

CATARACT DIAMOND KNIFE by Medical Technology Development Corp. — Product Code HNN

K863725 is an FDA 510(k) premarket notification submitted by Medical Technology Development Corp. for the device "CATARACT DIAMOND KNIFE". The FDA issued a decision of Substantially Equivalent on October 31, 1986. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Medical Technology Development Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
September 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Medical Technology Development Corp.

  • K941488 — DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER (November 30, 1994)
  • K862315 — FYODOROV COLLAGEN CORNEAL SHIELD (January 7, 1987)
  • K863727 — FIXATION INSTRUMENTS (October 31, 1986)
  • K863726 — INSTRUMENT STERILIZATION TRAY (October 14, 1986)

Other clearances for product code HNN

  • K110166 — CLEARCUT S SAFETY KNIFE (May 20, 2011)
  • K922378 — OPHTHALMIC KNIFE (December 10, 1992)
  • K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE (August 22, 1988)
  • K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900 (May 13, 1988)
  • K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE (April 13, 1988)
  • K874057 — OPHTHALMIC TIP & BLADE SCALPELS (December 23, 1987)
  • K874056 — OPHTHALMIC DISPOSABLE BLADES (December 22, 1987)
  • K873385 — OPHTHALMIC PHACO-BLADE (September 21, 1987)
  • K871285 — KNIFE, OPHTHALMIC (April 27, 1987)
  • K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (December 15, 1986)

FDA data resources