FDA 510(k)

ENDOPLUS

K-Number: K941969 · 1994-06-22

ApplicantWembley Rubber Products (M) Sdn Bhd

Decision Date1994-06-22

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ENDOPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1994-06-22 under 510(k) number K941969. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOPLUS?

ENDOPLUS is a medical device that received FDA 510(k) clearance on 1994-06-22. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K941969.

When did ENDOPLUS receive FDA 510(k) clearance?

ENDOPLUS received FDA 510(k) clearance on 1994-06-22, under 510(k) number K941969.

Who is the listed applicant for ENDOPLUS?

The FDA 510(k) record lists Wembley Rubber Products (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOPLUS?

The FDA product code for ENDOPLUS is BTR.

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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.