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FDA 510(k)

AMS MALLEABLE OR JONAS SILICONE-SILVER

K-Number: K792724 · 1980-09-09

ApplicantAmerican Medical Systems, Inc.
Decision Date1980-09-09
Product CodeFAE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMS MALLEABLE OR JONAS SILICONE-SILVER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K792724. The device is classified under product code FAE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMS MALLEABLE OR JONAS SILICONE-SILVER?

AMS MALLEABLE OR JONAS SILICONE-SILVER is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K792724.

When did AMS MALLEABLE OR JONAS SILICONE-SILVER receive FDA 510(k) clearance?

AMS MALLEABLE OR JONAS SILICONE-SILVER received FDA 510(k) clearance on 1980-09-09, under 510(k) number K792724.

Who is the listed applicant for AMS MALLEABLE OR JONAS SILICONE-SILVER?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMS MALLEABLE OR JONAS SILICONE-SILVER?

The FDA product code for AMS MALLEABLE OR JONAS SILICONE-SILVER is FAE.

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Other records listing American Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132655RETROARC RETROPUBIC SLING SYSTEMK112842AMS ELEVATE PCK100807MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191K092735GREENLIGHT XPS LASER SYSTEMK090934PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEMK090663AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

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Related Devices (Code: FAE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm DeviceBoston Scientific CorporationK181673Rigi10 Malleable Penile ProsthesisRigicon, Inc.K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.K082006AMS SPECTRA CONCEALABLE PENILE PROSTHESISAmerican Medical Systems, Inc.K040959MENTOR GENESIS PENILE PROSTHESISMentor Corp.K963328AMS AMBICOR PENILE PROSTHESISAmerican Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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