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FDA 510(k)

BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM

K-Number: K960810 · 1996-10-21

ApplicantMarlo Surgical Technology
Decision Date1996-10-21
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM is the device name listed in this FDA 510(k) record. The listed applicant is Marlo Surgical Technology. It received FDA 510(k) clearance on 1996-10-21 under 510(k) number K960810. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM?

BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM is a medical device that received FDA 510(k) clearance on 1996-10-21. The listed applicant is Marlo Surgical Technology. The 510(k) number is K960810.

When did BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM receive FDA 510(k) clearance?

BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM received FDA 510(k) clearance on 1996-10-21, under 510(k) number K960810.

Who is the listed applicant for BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM?

The FDA 510(k) record lists Marlo Surgical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM?

The FDA product code for BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM is HET.

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Other records listing Marlo Surgical Technology 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.

K962273MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NSTK924611IRRIGATION PUMP AND TUBING SETK932634NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURESK932832PRIMUS INSULATED FORCEPSK920611MARLOW LAPAROSCOPIC GRASPING FORCEPK914153OTT INSUFFLATOR FILTER PLUS/TUBING SET

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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