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FDA 510(k)

DACOMED PENILE PROSTHESIS SIZER

K-Number: K870320 · 1987-03-17

ApplicantDacomed Corp.
Decision Date1987-03-17
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DACOMED PENILE PROSTHESIS SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Dacomed Corp.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K870320. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DACOMED PENILE PROSTHESIS SIZER?

DACOMED PENILE PROSTHESIS SIZER is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Dacomed Corp.. The 510(k) number is K870320.

When did DACOMED PENILE PROSTHESIS SIZER receive FDA 510(k) clearance?

DACOMED PENILE PROSTHESIS SIZER received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870320.

Who is the listed applicant for DACOMED PENILE PROSTHESIS SIZER?

The FDA 510(k) record lists Dacomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DACOMED PENILE PROSTHESIS SIZER?

The FDA product code for DACOMED PENILE PROSTHESIS SIZER is JLW.

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Other records listing Dacomed Corp. 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.

K953640DUNA II PENILE PROSTHESISK941781RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEMK920409DACOMED BATTERY OPERATED VACUUM ERECTION DEVICEK920420DURA II PENILE PROSTHESISK912344MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESISK900774DACOMED NEGATIVE PRESSURE ERECTION DEVICE

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Related Devices (Code: JLW)

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.

K251543Atellica® IM TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)Siemens Healthcare DiagnosticsK234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0Genalyte, Inc.K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)Siemens Healthcare Diagnostics, Inc.K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, 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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