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FDA 510(k)

MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE

K-Number: K903419 · 1990-08-09

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1990-08-09
Product CodeGDH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K903419. The device is classified under product code GDH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE?

MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K903419.

When did MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE receive FDA 510(k) clearance?

MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE received FDA 510(k) clearance on 1990-08-09, under 510(k) number K903419.

Who is the listed applicant for MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE?

The FDA product code for MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE is GDH.

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Other records listing United States Surgical, A Division of Tyco Healthc 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.

K071406AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIERK071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORK061288AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIERK062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSK062326AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVEK061095AUTO SUTUR ENDO GIA STAPLERS

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Related Devices (Code: GDH)

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.

K900487MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVEUnited States Surgical, A Division of Tyco HealthcK891901GOUGES, ALEXANDER, BISHOP, LUCASZinnanti Surgical Instruments, Inc.K874879AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVEUnited States Surgical, A Division of Tyco HealthcK842822CHERMEL BONE GOUGESCher Mel Corp.K760850PARKES HUMP GAUGE STRAIGHT 7 (18 CM)V. Mueller O.V. Baxter Healthcare Corp.

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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