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510(k) K897093

INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. by Microline Pentax, Inc. — Product Code HNF

K897093 is an FDA 510(k) premarket notification submitted by Microline Pentax, Inc. for the device "INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.". The FDA issued a decision of Substantially Equivalent on April 4, 1990. The device falls under product code HNF (Scissors, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Microline Pentax, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1990
Date Received
December 20, 1989
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 Microline Pentax, Inc.

  • K013695 — MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIP (January 8, 2002)
  • K982984 — ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS (October 21, 1998)
  • K981389 — DISPOSABLE RE-NEW FORCEPS (May 29, 1998)
  • K981188 — ELECTROSURGICAL CAUTERY PROBES (May 20, 1998)
  • K980758 — 3 MM SELEC-TIP LAPAROSCOPIC SCISSORS (March 27, 1998)
  • K974066 — RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS (January 22, 1998)
  • K970826 — SELECTA-TIP LAPAROSCOPIC SCISSORS (March 28, 1997)
  • K962119 — RE-NEW LAPAROSCOPIC INSTRUMENTS (August 9, 1996)
  • K932648 — QUICK SWITCH LAPAROSCOPIC INSTRUMENTS (October 12, 1993)
  • K881049 — BRADBURY INTRAOCULAR RETINAL KIT CAT #200 (September 12, 1988)

Other clearances for product code HNF

  • K022840 — STEPHENS DISPOSABLE SCISSORS (November 1, 2002)
  • 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)
  • K821286 — IRIS SCISSORS STRAIGHT 4 1/2 (May 28, 1982)
  • K821290 — LITTAUER SCISSORS 5 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)
  • K770019 — SCISSORS, IRIS (January 12, 1977)

FDA data resources