Atlas FDA

Rigi10 Malleable Penile Prosthesis

FDA 510(k) clearance K181673 · decided 2019-04-15

Clearance details

K-number
K181673
Device name
Rigi10 Malleable Penile Prosthesis
Applicant
Rigicon, Inc.
Decision
Substantially Equivalent
Date received
2018-06-25
Decision date
2019-04-15
Days to decision
294 days
Clearance type
Abbreviated
Product code
FAE
Device class
2
Regulation number
876.3630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Hauppauge, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device (K183619)Boston Scientific Corporation2019-04-16
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K090663)American Medical Systems, Inc.2009-04-09
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS (K082006)American Medical Systems, Inc.2008-10-20
MENTOR GENESIS PENILE PROSTHESIS (K040959)Mentor Corp.2004-10-29
AMS AMBICOR PENILE PROSTHESIS (K963328)American Medical Systems, Inc.1996-12-04
DUNA II PENILE PROSTHESIS (K953640)Dacomed Corp.1995-10-27
AMS 650 MALLERABLE PENIEL PROSTHESIS (K951716)American Medical Systems, Inc.1995-07-06
DURA II PENILE PROSTHESIS (K920420)Dacomed Corp.1992-04-16
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS (K912935)American Medical Systems, Inc.1992-03-18
MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS (K912344)Dacomed Corp.1991-10-11
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS (K910214)American Medical Corp.1991-04-25
MINNOW PENILE IMPLANT PROTECTOR (K904262)Ruja-Med Medical Marketing1990-12-13

Recalls involving this device

No recalls on record reference this clearance.