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510(k) K844448

OMS/GONVERS RETINAL PERFORATOR by Optical Micro Systems, Inc. — Product Code HNM

K844448 is an FDA 510(k) premarket notification submitted by Optical Micro Systems, Inc. for the device "OMS/GONVERS RETINAL PERFORATOR". The FDA issued a decision of Substantially Equivalent on August 21, 1985. The device falls under product code HNM (Needle, Ophthalmic Suturing), a Class I device regulated under 21 CFR 886.4350. Optical Micro Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
November 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Optical Micro Systems, Inc.

  • K950218 — OMS SLIMLINE PHACO HANDPIECE (July 17, 1995)
  • K946054 — DIPLOMAX (July 11, 1995)
  • K935223 — OPHTHALMIC SURGICAL SYSTEM (March 14, 1994)
  • K935226 — I/V POLE (February 16, 1994)
  • K935003 — ELECTRIC I/V POLE OR EIVP2 (January 25, 1994)
  • K870068 — ASPIRATION REVERSAL CONTROL (ARC) MODULE (February 12, 1987)
  • K844373 — O.M.S. ULTRA-PHACO (December 19, 1985)
  • K844895 — OMS SILICONE OIL INJECTOR (June 24, 1985)
  • K844467 — OMS CRYO (February 22, 1985)
  • K844715 — VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY (January 22, 1985)

Other clearances for product code HNM

  • K780154 — NEEDLEHOLDER, MICROVASULAR 5 1/2 (March 17, 1978)

FDA data resources