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510(k) K841247

SPC DISPOSABLE CUTTER by Surgical Products Corp. — Product Code FZT

K841247 is an FDA 510(k) premarket notification submitted by Surgical Products Corp. for the device "SPC DISPOSABLE CUTTER". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800. Surgical Products Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
March 21, 1984
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 Surgical Products Corp.

  • K921671 — SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE (June 18, 1992)
  • K861614 — GHI WET PENCIL (July 8, 1986)
  • K841241 — ANTERIOR CRUCIATE LIGAMENT GRASPER (February 6, 1985)
  • K841328 — SPC ARTHROSCOPY TABLE (May 2, 1984)
  • K834434 — MACH I ELECTROSURGERY HAND CONTROL (April 25, 1984)

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)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K821632 — SURGICAL SCISSORS, SET OF 3 (June 24, 1982)
  • K821352 — CONPHAR IRIS SCISSORS (May 27, 1982)
  • K821361 — CONPHAR TONSIL SCISSORS (May 27, 1982)
  • K821355 — CONPHAR LITTAUER SCISSORS (May 27, 1982)
  • K821350 — CONPHAR WIRE CUTTING SCISSORS (May 27, 1982)

FDA data resources