Home / 510(k) Clearances / K851752

510(k) K851752

9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS by Artiberia — Product Code GDN

K851752 is an FDA 510(k) premarket notification submitted by Artiberia for the device "9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS". The FDA issued a decision of Substantially Equivalent on Jun 20, 1985. The device falls under product code GDN (Knife, Amputation), a Class I device regulated under 21 CFR 878.4800. Artiberia has 78 other 510(k) clearances on record.

Clearance details

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

Device classification

Device Name
Knife, Amputation
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type
510(k) Exempt

Other clearances by Artiberia

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

FDA data resources

Source: FDA 510(k) database entry for K851752. Report a data issue: hello@regdatalab.com.