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FDA 510(k)

4 SURE TM RECTAL TUBE

K-Number: K921852 · 1993-10-08

ApplicantBoston Pacific Medical, Inc.
Decision Date1993-10-08
Product CodeKMO
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

4 SURE TM RECTAL TUBE 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 1993-10-08 under 510(k) number K921852. The device is classified under product code KMO. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4 SURE TM RECTAL TUBE?

4 SURE TM RECTAL TUBE is a medical device that received FDA 510(k) clearance on 1993-10-08. The listed applicant is Boston Pacific Medical, Inc.. The 510(k) number is K921852.

When did 4 SURE TM RECTAL TUBE receive FDA 510(k) clearance?

4 SURE TM RECTAL TUBE received FDA 510(k) clearance on 1993-10-08, under 510(k) number K921852.

Who is the listed applicant for 4 SURE TM RECTAL TUBE?

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 RECTAL TUBE?

The FDA product code for 4 SURE TM RECTAL TUBE is KMO.

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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 CATHETERK9218534 SURE TM FEEDING TUBESK9218514 SURE TM SUCTION CATHETERS & KITS

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Related Devices (Code: KMO)

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.

K893809COUGH PILLOWCustom Hospitals ProductsK883214THORACIC SUPPORT SYSTEMStorer Medical ProductsK882592HEART HUGGER STERNUM SUPPORT HARNESSGeneral Cardiac Technology, Inc.K792629STERILIZATION PROCESS/T-BINDERProcter & Gamble Mfg. Co.

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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