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FDA 510(k)

STI TISSUE MANIPULATOR

K-Number: K911699 · 1991-06-13

ApplicantSurgical Technologies, Inc.
Decision Date1991-06-13
Product CodeHIN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

STI TISSUE MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1991-06-13 under 510(k) number K911699. The device is classified under product code HIN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STI TISSUE MANIPULATOR?

STI TISSUE MANIPULATOR is a medical device that received FDA 510(k) clearance on 1991-06-13. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K911699.

When did STI TISSUE MANIPULATOR receive FDA 510(k) clearance?

STI TISSUE MANIPULATOR received FDA 510(k) clearance on 1991-06-13, under 510(k) number K911699.

Who is the listed applicant for STI TISSUE MANIPULATOR?

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

What is the FDA product code for STI TISSUE MANIPULATOR?

The FDA product code for STI TISSUE MANIPULATOR is HIN.

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Other records listing Surgical Technologies, 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.

K941992CYSTOSCOPEK942029ARTHROSCOPEK946136INFINITECH LIGHTED INFUSION CANNULAK952566OSCILFLATORK951918SURGICAL TECHNOLOGIES, INC. SYRINGEK950683ARTHROGRAM TRAY

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Related Devices (Code: HIN)

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.

K130305LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZELina Medical ApsK122983KSEA BIPOLAR ELECTRODEKARL STORZ Endoscopy-America, Inc.K122605PKS BILLGyrus Acmi, Inc.K113080TUBALGATORMectra Labs, Inc.K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSETHICON, Inc.K111059GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)Gyrus Acmi, Inc.

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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