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510(k) K851749

1-380 PINWHEEL (WARTENBERG) by Artiberia — Product Code GWY

K851749 is an FDA 510(k) premarket notification submitted by Artiberia for the device "1-380 PINWHEEL (WARTENBERG)". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code GWY (Pinwheel), a Class I device regulated under 21 CFR 882.1750. Artiberia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1985
Date Received
April 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pinwheel
Device Class
Class I
Regulation Number
882.1750
Review Panel
NE
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 GWY

  • K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
  • K942926 — NEURO-AIDE (August 3, 1994)
  • K871167 — SENSITESTER (April 1, 1987)
  • K780422 — PINWHEEL (April 4, 1978)

FDA data resources