Atlas FDA

BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM

FDA 510(k) clearance K061788 · decided 2006-07-11

Clearance details

K-number
K061788
Device name
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
Applicant
Boehringer Laboratories
Decision
Substantially Equivalent
Date received
2006-06-26
Decision date
2006-07-11
Days to decision
15 days
Clearance type
Traditional
Product code
OMP
Device class
2
Regulation number
878.4780
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Norristown, PA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy recall (Z-2609-2010)Convatec Inc.2010-09-28
ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, ( recall (Z-1814-2009)ConvaTec2009-09-29
Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; recall (Z-2043-2009)ConvaTec2009-09-09
Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, recall (Z-2044-2009)ConvaTec2009-09-09
Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pre recall (Z-2045-2009)ConvaTec2009-09-09