FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

KAM SUCKER

K Number: K822065 · Decision Aug 16, 1982
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
60
Review Days
33

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Basic Information

Device Name
KAM SUCKER
K Number
K822065
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
The Anspach Effort, Inc.
Date Received
July 14, 1982
Decision Date
August 16, 1982
Product Code
KDC
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
KDC Instrument, Surgical, Disposable

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K220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
K183545 Anspach Helix Dissection Tools
K180063 OCM-G1 Attachment
K133604 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
K131053 ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
K113476 ANSPACH DISSECTION TOOLS
K082637 CRANIAL PERFORATOR
K080802 EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
K061297 ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K063688 SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
Search all 60 clearances from The Anspach Effort, Inc. →