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510(k) K771806

THOREK SCISSORS 7 1/4 & 10 by J. Sklar Mfg. Co., Inc. — Product Code FZT

K771806 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "THOREK SCISSORS 7 1/4 & 10". The FDA issued a decision of Substantially Equivalent on October 4, 1977. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1977
Date Received
September 23, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cutter, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 FZT

  • K112400 — SMARTSHEARS (September 12, 2011)
  • K890818 — AUTO SUTURE DISPOSABLE SURGICAL TROCAR* (May 4, 1989)
  • K872990 — MICRINS SURGICAL SCISSOR (August 17, 1987)
  • K841741 — SINGLE HAIR TRANSPLANT GRAFT (July 23, 1984)
  • K841247 — SPC DISPOSABLE CUTTER (May 2, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K821632 — SURGICAL SCISSORS, SET OF 3 (June 24, 1982)
  • K821350 — CONPHAR WIRE CUTTING SCISSORS (May 27, 1982)
  • K821361 — CONPHAR TONSIL SCISSORS (May 27, 1982)
  • K821352 — CONPHAR IRIS SCISSORS (May 27, 1982)

FDA data resources