Atlas FDA

SURGICAL DESIGN CIRCUMCISION CLAMP

FDA 510(k) clearance K043533 · decided 2005-04-01

Clearance details

K-number
K043533
Device name
SURGICAL DESIGN CIRCUMCISION CLAMP
Applicant
Surgical Design, Inc.
Decision
Substantially Equivalent
Date received
2004-12-22
Decision date
2005-04-01
Days to decision
100 days
Clearance type
Traditional
Product code
HFX
Device class
2
Regulation number
884.4530
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Lorton, VA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to recall (Z-2153-2011)Surgical Design Inc2011-05-06