Atlas FDA

Neptune E-SEP Smoke Evacuation Pencil

FDA 510(k) clearance K160693 · decided 2016-04-13

Clearance details

K-number
K160693
Device name
Neptune E-SEP Smoke Evacuation Pencil
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2016-03-14
Decision date
2016-04-13
Days to decision
30 days
Clearance type
Special
Product code
GEI
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19