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FDA 510(k)

4 SURE TM COLOSTOMY POUCH

K-Number: K922401 · 1992-06-10

ApplicantBoston Pacific Medical, Inc.
Decision Date1992-06-10
Product CodeEZQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4 SURE TM COLOSTOMY POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Boston Pacific Medical, Inc.. It received FDA 510(k) clearance on 1992-06-10 under 510(k) number K922401. The device is classified under product code EZQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4 SURE TM COLOSTOMY POUCH?

4 SURE TM COLOSTOMY POUCH is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is Boston Pacific Medical, Inc.. The 510(k) number is K922401.

When did 4 SURE TM COLOSTOMY POUCH receive FDA 510(k) clearance?

4 SURE TM COLOSTOMY POUCH received FDA 510(k) clearance on 1992-06-10, under 510(k) number K922401.

Who is the listed applicant for 4 SURE TM COLOSTOMY POUCH?

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

What is the FDA product code for 4 SURE TM COLOSTOMY POUCH?

The FDA product code for 4 SURE TM COLOSTOMY POUCH is EZQ.

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Other records listing Boston Pacific Medical, 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.

K9331094SURE URO-LINK UROLOGICAL PROCEDURE TRAYSK9224024 SURE TM ENTERAL FEEDING BAGK9310484-SURE NELATON CATHETERK9310474-SURE FEMALE CATHETERK9218524 SURE TM RECTAL TUBEK9218534 SURE TM FEEDING TUBES

View all 11 devices →

Related Devices (Code: EZQ)

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.

K111365VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.K102536VITALA CONTINENCE CONTROL DEVICEConvatec, Inc.K083785VITALA CONTINENCE CONTROL DEVICEConvatecK880327MARLEN ULTRA ILEOSTOMY POUCH-5000Marlen Mfg. & Development Co.K863830CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEMColoplast A/S

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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