Atlas FDA

FAE

32 FDA 510(k) clearances · Product code

92 daysmedian time to decision
253 days90th percentile
32clearances measured

FDA profile

Official device name
Prosthesis, Penile
Device class
Class II (moderate risk)
Regulation
21 CFR 876.3630
Medical specialty
Gastroenterology, Urology
Flags
Implant
Adverse events (MAUDE)
2021: 167 · 2022: 168 · 2023: 160 · 2024: 187 · 2025: 197 · 2026: 107
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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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
Rigi10 Malleable Penile Prosthesis (K181673)Rigicon, Inc.2019-04-15
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
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES (K900371)Mentor Corp.1990-11-02
700 ULTREX PENILE PROSTHESIS 12MM DIAMETER (K901482)American Medical Systems, Inc.1990-06-27
AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS (K896941)American Medical Systems, Inc.1990-03-06
MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE) (K890402)Mentor Corp.1989-08-03
DURAPHASE PENILE PROSTHESIS (K871653)Dacomed Corp.1987-09-18
BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS (K864040)C.R. Bard, Inc.1986-10-24
MENTOR CORPORAL DILATORS (K860517)Mentor Corp.1986-03-11
OMNI PHASE PENILE PROSTHESIS (K850019)Dacomed Corp.1985-04-09
MALLEABLE PENILE PROSTHESIS (K843280)Mentor Corp.1984-10-24
FLEXI-FLATE PENILE IMPLANT (K834347)Surgitek1984-04-02
ESKA JONAS SILICON-SILVER PENILE (K834504)Dacomed Corp.1984-02-04
SURGIKEK PENILE PROSTHESIS TAIL EXTEND (K832043)Medical Engineering Corp.1983-10-20
AMS MALLEABLE PENILE PROSTHESIS (K831660)American Medical Systems, Inc.1983-08-08
SURGITEK SIZER FOR PENILE PROSTHESIS (K830917)Medical Engineering Corp.1983-04-12
INFLATABLE PENILE PROSTH. - CYLINDER (K830048)American Medical Systems, Inc.1983-04-12
THE INFLATABLE PENILE PROSTHESIS (K821628)American Medical Systems, Inc.1982-08-10
ESKA JONAS SILICONE-SILVER PENILE PROST (K820081)Dacomed Corp.1982-01-25
ERECTAID (K803111)Burditt & Calkins-Siemens-Elema1981-01-23
AMS MALLEABLE OR JONAS SILICONE-SILVER (K792724)American Medical Systems, Inc.1980-09-09

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Every clearance here is in the API, with alerts when new ones post.