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FDA 510(k)

SURGICOT 2 INDICATOR SYSTEM

K-Number: K800029 · 1980-03-12

ApplicantSurgicot, Inc.
Decision Date1980-03-12
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICOT 2 INDICATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgicot, Inc.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800029. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICOT 2 INDICATOR SYSTEM?

SURGICOT 2 INDICATOR SYSTEM is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Surgicot, Inc.. The 510(k) number is K800029.

When did SURGICOT 2 INDICATOR SYSTEM receive FDA 510(k) clearance?

SURGICOT 2 INDICATOR SYSTEM received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800029.

Who is the listed applicant for SURGICOT 2 INDICATOR SYSTEM?

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

What is the FDA product code for SURGICOT 2 INDICATOR SYSTEM?

The FDA product code for SURGICOT 2 INDICATOR SYSTEM is FRC.

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Other records listing Surgicot, Inc. 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.

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Related Devices (Code: FRC)

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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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