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FDA 510(k)

HOLLISTER RETRACTED PENIS POUCH

K-Number: K970443 · 1997-02-25

ApplicantHollister, Inc.
Decision Date1997-02-25
Product CodeEXI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER RETRACTED PENIS POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1997-02-25 under 510(k) number K970443. 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 HOLLISTER RETRACTED PENIS POUCH?

HOLLISTER RETRACTED PENIS POUCH is a medical device that received FDA 510(k) clearance on 1997-02-25. The listed applicant is Hollister, Inc.. The 510(k) number is K970443.

When did HOLLISTER RETRACTED PENIS POUCH receive FDA 510(k) clearance?

HOLLISTER RETRACTED PENIS POUCH received FDA 510(k) clearance on 1997-02-25, under 510(k) number K970443.

Who is the listed applicant for HOLLISTER RETRACTED PENIS POUCH?

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

What is the FDA product code for HOLLISTER RETRACTED PENIS POUCH?

The FDA product code for HOLLISTER RETRACTED PENIS POUCH is EXI.

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Other records listing Hollister, Inc. as applicant

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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.K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, 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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