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FDA 510(k)

TROCAR SLEEVE

K-Number: K931561 · 1994-02-07

ApplicantL.A.S.E.R., Inc.
Decision Date1994-02-07
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TROCAR SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is L.A.S.E.R., Inc.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K931561. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROCAR SLEEVE?

TROCAR SLEEVE is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is L.A.S.E.R., Inc.. The 510(k) number is K931561.

When did TROCAR SLEEVE receive FDA 510(k) clearance?

TROCAR SLEEVE received FDA 510(k) clearance on 1994-02-07, under 510(k) number K931561.

Who is the listed applicant for TROCAR SLEEVE?

The FDA 510(k) record lists L.A.S.E.R., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TROCAR SLEEVE?

The FDA product code for TROCAR SLEEVE is HET.

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Other records listing L.A.S.E.R., 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.

K983965CO2 LASER COUPLERK950021REUSABLE TROCAR WITH SAFETY SLEEVEK940454GRASPING FORCEPS, PUNCHES, SCISSORSK933421ENDOSCOPIC INSTRUMENTS AND ACCESSDORIESK924844BULK TISSUE REMOVAL SYSTEMK932045DISPOSABLE INSUFFLATION TUBING

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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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