FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

THE CART

K Number: K872533 · Decision Nov 2, 1987
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
29
Review Days
129

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Basic Information

Device Name
THE CART
K Number
K872533
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.1100
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Arthropedics, Inc.
Date Received
June 26, 1987
Decision Date
November 2, 1987
Product Code
HRX
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

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

Product Code Device Name
HRX Arthroscope

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Other Clearances by Arthropedics, Inc.

K Number Device Name
K873619 ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)
K873655 MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
K873653 MONOPOLAR CAUTERY BLADE TIP #TM-1701
K873654 MONOPOLAR CAUTERY CONICAL TIP #TM-1702
K873387 VIDEO ARTHROSCOPE, 1.7MM X 55 MM
K873504 CUP BIOPSY FORCEPS, RIGHT
K873501 SCISSOR, LEFT
K873502 SCISSOR, RIGHT
K873512 SERRATED GRASPING FORCEPS, RIGHT
K873710 MAGNETIC RETRIEVER, 1.7MM W/LUER FITTING TM-1350
Search all 29 clearances from Arthropedics, Inc. →