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FDA 510(k)

AUTO SUTURE SURGIPORT SPIRAL SLEEVE

K-Number: K900123 · 1990-04-04

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1990-04-04
Product CodeFBQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE SURGIPORT SPIRAL 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 1990-04-04 under 510(k) number K900123. The device is classified under product code FBQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE SURGIPORT SPIRAL SLEEVE?

AUTO SUTURE SURGIPORT SPIRAL SLEEVE is a medical device that received FDA 510(k) clearance on 1990-04-04. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K900123.

When did AUTO SUTURE SURGIPORT SPIRAL SLEEVE receive FDA 510(k) clearance?

AUTO SUTURE SURGIPORT SPIRAL SLEEVE received FDA 510(k) clearance on 1990-04-04, under 510(k) number K900123.

Who is the listed applicant for AUTO SUTURE SURGIPORT SPIRAL 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 AUTO SUTURE SURGIPORT SPIRAL SLEEVE?

The FDA product code for AUTO SUTURE SURGIPORT SPIRAL SLEEVE is FBQ.

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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: FBQ)

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.

K012198GIBBONS STERILE TROCAR KITSGibbons Surgical Corp.K980804SABRE BT BLUNT0TIP SURGICAL TROCAREndoscopic Concepts, Inc.K944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITGabris Surgical Corp.K944104GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.K942885AUTO SUTURE MODIFIED GRIPUnited States Surgical, A Division of Tyco HealthcK934724AESCULAP TROCAR INSTRUMENT SETAesculap, 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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