FDA 510(k)

TEFLON COATED RESECTOSCOPE SHEATH

K-Number: K761242 · 1976-12-16

ApplicantV. Mueller O.V. Baxter Healthcare Corp.

Decision Date1976-12-16

Product CodeFJL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TEFLON COATED RESECTOSCOPE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is V. Mueller O.V. Baxter Healthcare Corp.. It received FDA 510(k) clearance on 1976-12-16 under 510(k) number K761242. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEFLON COATED RESECTOSCOPE SHEATH?

TEFLON COATED RESECTOSCOPE SHEATH is a medical device that received FDA 510(k) clearance on 1976-12-16. The listed applicant is V. Mueller O.V. Baxter Healthcare Corp.. The 510(k) number is K761242.

When did TEFLON COATED RESECTOSCOPE SHEATH receive FDA 510(k) clearance?

TEFLON COATED RESECTOSCOPE SHEATH received FDA 510(k) clearance on 1976-12-16, under 510(k) number K761242.

Who is the listed applicant for TEFLON COATED RESECTOSCOPE SHEATH?

The FDA 510(k) record lists V. Mueller O.V. Baxter Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEFLON COATED RESECTOSCOPE SHEATH?

The FDA product code for TEFLON COATED RESECTOSCOPE SHEATH is FJL.

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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.