FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

Anthogyr Surgical Cassettes

K Number: K230680 · Decision Jul 11, 2023
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
10
Review Days
120

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Basic Information

Device Name
Anthogyr Surgical Cassettes
K Number
K230680
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6850
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Anthogyr
Date Received
March 13, 2023
Decision Date
July 11, 2023
Product Code
KCT
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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Other Clearances by Anthogyr

K Number Device Name
K231072 Anthogyr FlexiBase® titanium bases for Axiom® BL
K233264 Anthogyr INTEGRAL Guided Surgery Cassettes
K230104 Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
K160730 Instrument kits
K093894 ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
K090676 MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K040671 EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
K041279 IMPLANTEO IMPLANTOLOGY MOTOR
K040674 IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES