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FDA 510(k)

HOLLISTER PREMIUM URINE COLLECTOR

K-Number: K931277 · 1993-06-23

ApplicantHollister, Inc.
Decision Date1993-06-23
Product CodeEXI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HOLLISTER PREMIUM URINE COLLECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1993-06-23 under 510(k) number K931277. 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 PREMIUM URINE COLLECTOR?

HOLLISTER PREMIUM URINE COLLECTOR is a medical device that received FDA 510(k) clearance on 1993-06-23. The listed applicant is Hollister, Inc.. The 510(k) number is K931277.

When did HOLLISTER PREMIUM URINE COLLECTOR receive FDA 510(k) clearance?

HOLLISTER PREMIUM URINE COLLECTOR received FDA 510(k) clearance on 1993-06-23, under 510(k) number K931277.

Who is the listed applicant for HOLLISTER PREMIUM URINE COLLECTOR?

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 PREMIUM URINE COLLECTOR?

The FDA product code for HOLLISTER PREMIUM URINE COLLECTOR is EXI.

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Other records listing Hollister, 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.

K123804INSTAFLO BOWEL CATHETER SYSTEM KITK100273INSTAFLO BOWEL CATHETER SYSTEM KITK090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,K083153ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007K050483EVADRI BLADDER CONTROL SYSTEMSK040779RESTORE WOUND CLEANSER

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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.K963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICEBioderm, 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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