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510(k) K852706

VERSABLADE by Alphamedix, Inc. — Product Code HNN

K852706 is an FDA 510(k) premarket notification submitted by Alphamedix, Inc. for the device "VERSABLADE". The FDA issued a decision of SN on November 4, 1985. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Alphamedix, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
November 4, 1985
Date Received
June 26, 1985
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 Alphamedix, Inc.

  • K852633 — VERSABLADE (November 4, 1985)
  • K851272 — VERSAPHAGE (July 5, 1985)
  • K830812 — ALPHAMEDIX I/A HAND-PIECE, 500-001 (June 8, 1983)
  • K830703 — GLOMARK (April 28, 1983)
  • K820363 — DISPOSABLE SURGICAL GARMENTS (March 8, 1982)
  • K820008 — VERSATOME I (February 22, 1982)

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