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FDA 510(k)

GENTLE BACK, PLASTIC URINARY DRAINAGE BAG

K-Number: K861192 · 1986-04-23

ApplicantAdvanced Clinical Products, Inc.
Decision Date1986-04-23
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENTLE BACK, PLASTIC URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Clinical Products, Inc.. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K861192. 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 GENTLE BACK, PLASTIC URINARY DRAINAGE BAG?

GENTLE BACK, PLASTIC URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Advanced Clinical Products, Inc.. The 510(k) number is K861192.

When did GENTLE BACK, PLASTIC URINARY DRAINAGE BAG receive FDA 510(k) clearance?

GENTLE BACK, PLASTIC URINARY DRAINAGE BAG received FDA 510(k) clearance on 1986-04-23, under 510(k) number K861192.

Who is the listed applicant for GENTLE BACK, PLASTIC URINARY DRAINAGE BAG?

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

What is the FDA product code for GENTLE BACK, PLASTIC URINARY DRAINAGE BAG?

The FDA product code for GENTLE BACK, PLASTIC URINARY DRAINAGE BAG is KNX.

Related Clinical Trials

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.

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Other records listing Advanced Clinical Products, 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.

K871387SECOND NATURE(TM)K862580NEPHROSTOMY DRAINAGE KIT (A-150)K862581NEPHROSTOMY CONNECTING TUBE (A-50)

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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