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FDA 510(k)

BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE

K-Number: K963950 · 1997-01-10

ApplicantBioderm, Inc.
Decision Date1997-01-10
Product CodeEXI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bioderm, Inc.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K963950. The device is classified under product code EXI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE?

BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Bioderm, Inc.. The 510(k) number is K963950.

When did BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE receive FDA 510(k) clearance?

BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE received FDA 510(k) clearance on 1997-01-10, under 510(k) number K963950.

Who is the listed applicant for BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE?

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

What is the FDA product code for BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE?

The FDA product code for BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE is EXI.

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Other records listing Bioderm, 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.

K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSINGK982778BIODERM FOAM WOUND DRESSINGK982939BTF THIN FILM WOUND DRESSINGK980451BIODERM CALCIUM ALGINATE DRESSINGK973429BIODERM FOAM WOUND DRESSINGK963602BIODERM PVP FOAM WOUND DRESSING

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Related Devices (Code: EXI)

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.

K971499FEMALE EXTERNAL URINARY COLLECTION POUCHMediquest, Inc.K970443HOLLISTER RETRACTED PENIS POUCHHollister, Inc.K931277HOLLISTER PREMIUM URINE COLLECTORHollister, Inc.K924755CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTIONConvatec, A Division of E.R. Squibb & SonsK915246CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)Coloplast A/SK915616URIHESIVE STRIPConvatec, A Division of E.R. Squibb & Sons

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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