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510(k) K770019

SCISSORS, IRIS by J. Sklar Mfg. Co., Inc. — Product Code HNF

K770019 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "SCISSORS, IRIS". The FDA issued a decision of Substantially Equivalent on January 12, 1977. The device falls under product code HNF (Scissors, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1977
Date Received
January 5, 1977
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 J. Sklar Mfg. Co., Inc.

  • K843693 — JACOBS HIGH VACUUM SUCTION UNIT 05-2570 (October 31, 1984)
  • K842112 — TISCHLER CERVICAL BIOPSY PUNCH FORCEPS (July 3, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K802458 — KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 (January 12, 1981)
  • K802457 — KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 (January 12, 1981)
  • K801273 — MAGILL CATHETER INTRO. FORCEPS (July 28, 1980)
  • K800441 — RUDD-CLINIC HEMORRHOIDAL FORCEPS (April 8, 1980)
  • K790577 — HEMORRHOIDAL LIGATOR (April 23, 1979)
  • K772230 — CANNULA, PERFUSION, FALLOPIAN TUBE (January 3, 1978)

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