Atlas FDA

3M ARTHROSCOPIC SURGICAL SYSTEM

FDA 510(k) clearance K855216 · decided 1986-03-04

Clearance details

K-number
K855216
Device name
3M ARTHROSCOPIC SURGICAL SYSTEM
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1985-12-30
Decision date
1986-03-04
Days to decision
64 days
Clearance type
Traditional
Product code
HWE
Device class
1
Regulation number
878.4820
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Cottae Grove, MN, US
Third-party review
No
Expedited review
No

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REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (K022744)Medical Device Services2002-09-18
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22