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510(k) K821352

CONPHAR IRIS SCISSORS by Conphar, Inc. — Product Code FZT

K821352 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR IRIS SCISSORS". The FDA issued a decision of Substantially Equivalent on May 27, 1982. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800. Conphar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1982
Date Received
May 5, 1982
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 Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (August 10, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821289 — MAYO-HEGAR NEEDLE HOLDER (June 3, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (June 3, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)
  • K821298 — BACKHAUS CLAMP, 3 1/2 (May 28, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)

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)
  • 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