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FDA 510(k)

SUR-FIT NIGHT DRAINAGE CONTAINER SET

K-Number: K842395 · 1984-08-08

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1984-08-08
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SUR-FIT NIGHT DRAINAGE CONTAINER SET is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1984-08-08 under 510(k) number K842395. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUR-FIT NIGHT DRAINAGE CONTAINER SET?

SUR-FIT NIGHT DRAINAGE CONTAINER SET is a medical device that received FDA 510(k) clearance on 1984-08-08. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K842395.

When did SUR-FIT NIGHT DRAINAGE CONTAINER SET receive FDA 510(k) clearance?

SUR-FIT NIGHT DRAINAGE CONTAINER SET received FDA 510(k) clearance on 1984-08-08, under 510(k) number K842395.

Who is the listed applicant for SUR-FIT NIGHT DRAINAGE CONTAINER SET?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUR-FIT NIGHT DRAINAGE CONTAINER SET?

The FDA product code for SUR-FIT NIGHT DRAINAGE CONTAINER SET is KNX.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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