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FDA 510(k)

INCARE PINSITE DRESSING

K-Number: K905206 · 1991-04-12

ApplicantHollister, Inc.
Decision Date1991-04-12
Product CodeKOZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCARE PINSITE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1991-04-12 under 510(k) number K905206. The device is classified under product code KOZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCARE PINSITE DRESSING?

INCARE PINSITE DRESSING is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Hollister, Inc.. The 510(k) number is K905206.

When did INCARE PINSITE DRESSING receive FDA 510(k) clearance?

INCARE PINSITE DRESSING received FDA 510(k) clearance on 1991-04-12, under 510(k) number K905206.

Who is the listed applicant for INCARE PINSITE DRESSING?

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 INCARE PINSITE DRESSING?

The FDA product code for INCARE PINSITE DRESSING is KOZ.

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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: KOZ)

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.

K905688CUTINOVA HYDROBeiersdorf, Inc.K905069IODOSORB GELPerstorp AB C/O Robert Joel SlomoffK904604REDI-RELEASE ABSORBENT DRESSINGFountain Pharmaceuticals, Inc.K896828BIOCLUSIVE(R) ABSORBENT DRESSINGJohnson & Johnson InternationalK903645DERMASORB WOUND CONTACT LAYER DRESSINGConvatec, A Division of E.R. Squibb & SonsK904412ALLEVYN DRESSING CLAIMS CHANGESmith & Nephew United, 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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