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510(k) K851781

25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES by Artiberia — Product Code GDL

K851781 is an FDA 510(k) premarket notification submitted by Artiberia for the device "25-420 TO 25-436 VARIOUS TYPES OF SUTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on June 20, 1985. The device falls under product code GDL (Needle, Suturing, Reusable), a Class I device regulated under 21 CFR 878.4800. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Suturing, Reusable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Artiberia

  • K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B (August 29, 1985)
  • K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF (July 9, 1985)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (July 2, 1985)
  • K851721 — 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (July 2, 1985)
  • K851723 — 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS (July 2, 1985)
  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (July 2, 1985)
  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (July 2, 1985)
  • K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (July 2, 1985)
  • K851730 — 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST (July 2, 1985)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (July 2, 1985)

Other clearances for product code GDL

  • K881394 — NON-STERILE SUTURE NEEDLES (April 8, 1988)
  • K851782 — 25-450 TO 25-540 VARIOUS SUTURE FORCEPS (June 20, 1985)
  • K813589 — SHARTPOINT EYED NEEDLES (January 18, 1982)
  • K812566 — UNIVERSAL SUTURE PASSER (November 10, 1981)

FDA data resources