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510(k) K861491

ROPHAE DIAMOND KNIFE by Rophae Lens Co., Inc. — Product Code HNN

K861491 is an FDA 510(k) premarket notification submitted by Rophae Lens Co., Inc. for the device "ROPHAE DIAMOND KNIFE". The FDA issued a decision of Substantially Equivalent on May 28, 1986. The device falls under product code HNN (Knife, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Rophae Lens Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1986
Date Received
April 22, 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 Rophae Lens Co., Inc.

  • K861545 — IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES (May 28, 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