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510(k) K811245

OPHTHALMIC SCISSORS by Keeler Instruments, Inc. — Product Code HNF

K811245 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "OPHTHALMIC SCISSORS". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code HNF (Scissors, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
May 4, 1981
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 Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

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)
  • K770041 — SCISSORS, STRABISMUS, 4 CURVED (January 14, 1977)
  • K770040 — SCISSORS, STRABIMUS, 4 STRAIGHT (January 14, 1977)
  • K770019 — SCISSORS, IRIS (January 12, 1977)

FDA data resources