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FDA 510(k)

SURG/ASSIST MODEL SA-1

K-Number: K912422 · 1991-08-12

ApplicantSurg-Assist, Inc.
Decision Date1991-08-12
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURG/ASSIST MODEL SA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Surg-Assist, Inc.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K912422. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURG/ASSIST MODEL SA-1?

SURG/ASSIST MODEL SA-1 is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Surg-Assist, Inc.. The 510(k) number is K912422.

When did SURG/ASSIST MODEL SA-1 receive FDA 510(k) clearance?

SURG/ASSIST MODEL SA-1 received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912422.

Who is the listed applicant for SURG/ASSIST MODEL SA-1?

The FDA 510(k) record lists Surg-Assist, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURG/ASSIST MODEL SA-1?

The FDA product code for SURG/ASSIST MODEL SA-1 is FYD.

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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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