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510(k) K760326

SURGICAL INSTRUMENTS, OPTHALMIC by Depuy, Inc. — Product Code HNF

K760326 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "SURGICAL INSTRUMENTS, OPTHALMIC". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code HNF (Scissors, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

Other clearances for product code HNF

  • K022840 — STEPHENS DISPOSABLE SCISSORS (November 1, 2002)
  • K897093 — INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. (April 4, 1990)
  • K873099 — MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (September 4, 1987)
  • K851768 — 13-550,13-560 WESCOTT SCOSSORS (EYE) (June 20, 1985)
  • K822151 — SURGICAL INSTRUMENTS REPRESENT. 4 CLASS (August 19, 1982)
  • K821290 — LITTAUER SCISSORS 5 1/2 (May 28, 1982)
  • K821286 — IRIS SCISSORS STRAIGHT 4 1/2 (May 28, 1982)
  • K811245 — OPHTHALMIC SCISSORS (July 31, 1981)
  • K770040 — SCISSORS, STRABIMUS, 4 STRAIGHT (January 14, 1977)
  • K770041 — SCISSORS, STRABISMUS, 4 CURVED (January 14, 1977)

FDA data resources