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Dacomed Penile Prosthesis Sizer

by Dacomed Corp. 510(k)

Active United States

510(k) K870320

Overview

The device is a penile prosthesis sizer, used to determine the appropriate size of a penile prosthesis for implantation. It is a medical device classified under product code JLW and regulation number 862.1690.

It received traditional 510(k) clearance from the FDA (K870320) on March 17, 1987, and is manufactured by Dacomed Corp. in Minneapolis, Minnesota. The device is supplied non-sterile and is intended for reusable use in clinical settings.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870320 Date17 Mar 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JLW
Device Class
Class II
Regulation
21 CFR Part 862.1690
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Dacomed Corp.

See all devices from Dacomed Corp. →

Questions

  • What is the DACOMED PENILE PROSTHESIS SIZER used for?

    The device is used to determine the appropriate size of a penile prosthesis for implantation, helping clinicians select the correct prosthesis size based on patient anatomy before surgery.

  • Is the DACOMED PENILE PROSTHESIS SIZER supplied sterile or non-sterile?

    The device is supplied non-sterile, as stated in the device data, and must be cleaned and sterilized by the user before each clinical use according to institutional protocols.

  • Is the DACOMED PENILE PROSTHESIS SIZER intended for single-use or reusable use?

    The device is intended for reusable use in clinical settings, meaning it can be cleaned, sterilized, and used multiple times following appropriate reprocessing procedures.

  • What regulatory pathway was used for the DACOMED PENILE PROSTHESIS SIZER?

    The device received traditional 510(k) clearance from the FDA (K870320) on March 17, 1987, indicating it was found substantially equivalent to a legally marketed predicate device.

  • Who manufactures the DACOMED PENILE PROSTHESIS SIZER and where is it made?

    The device is manufactured by Dacomed Corp. in Minneapolis, Minnesota, as specified in the device data under manufacturer and address details.