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

KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER

K Number: K871891 · Decision Jun 5, 1987
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
55
Applicant Total
334
Review Days
21

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Basic Information

Device Name
KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
K Number
K871891
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4820
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
KARL STORZ Endoscopy-America, Inc.
Date Received
May 15, 1987
Decision Date
June 5, 1987
Product Code
HSZ
Advisory Committee
General, Plastic Surgery
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
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

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Other Clearances by KARL STORZ Endoscopy-America, Inc.

K Number Device Name
K252624 KARL STORZ Laryngoscopes and Accessories
K223923 HOPKINS Telescopes
K202957 Flexible Video Cysto-Urethroscope (C-view)
K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
K201135 Image1 S CCU, Image1 S 4U Camera Head
K200740 HD Video Rhino Laryngoscope
K191357 Flexible HD Cysto-Urethroscope System
K182723 Flexible HD Cysto-Urethroscope System
K182186 CMOS Video-Rhino-Laryngoscope System
K183264 Flex-THOR scope
Search all 334 clearances from KARL STORZ Endoscopy-America, Inc. →