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FDA 510(k)

SOF-FLEX LAPAROSCOPIC BASKET

K-Number: K913299 · 1992-02-14

ApplicantCook Ob/Gyn
Decision Date1992-02-14
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOF-FLEX LAPAROSCOPIC BASKET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1992-02-14 under 510(k) number K913299. 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 SOF-FLEX LAPAROSCOPIC BASKET?

SOF-FLEX LAPAROSCOPIC BASKET is a medical device that received FDA 510(k) clearance on 1992-02-14. The listed applicant is Cook Ob/Gyn. The 510(k) number is K913299.

When did SOF-FLEX LAPAROSCOPIC BASKET receive FDA 510(k) clearance?

SOF-FLEX LAPAROSCOPIC BASKET received FDA 510(k) clearance on 1992-02-14, under 510(k) number K913299.

Who is the listed applicant for SOF-FLEX LAPAROSCOPIC BASKET?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOF-FLEX LAPAROSCOPIC BASKET?

The FDA product code for SOF-FLEX LAPAROSCOPIC BASKET is HET.

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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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