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510(k) K874963

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS by Solway, Inc. — Product Code HNA

K874963 is an FDA 510(k) premarket notification submitted by Solway, Inc. for the device "MANUAL OPHTHALMIC SURGICAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on December 23, 1987. The device falls under product code HNA (Spud, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Solway, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1987
Date Received
December 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Solway, Inc.

  • K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTS (February 5, 1988)
  • K874962 — FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (February 2, 1988)
  • K874956 — SELF-RETAINING RETRACTOR FOR NEUROSURGERY (January 28, 1988)
  • K874964 — DENTAL HAND INSTRUMENTS (January 27, 1988)
  • K875043 — RONGEUR (NEUROSURGICAL INSTRUMENTS) (January 22, 1988)
  • K874966 — TUNING FORKS (January 4, 1988)
  • K874965 — MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE (December 30, 1987)
  • K874950 — MICROSURGICAL INSTRUMENTS (December 30, 1987)
  • K874954 — MANUAL RONGEUR (December 30, 1987)
  • K874952 — MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES (December 30, 1987)

Other clearances for product code HNA

  • K931449 — MSP OPHTHALMIC (EYE SPUD) (August 31, 1993)

FDA data resources