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FDA 510(k)

AUTO SUTURE PSS SKIN STAPLING INSTRUMENT

K-Number: K810187 · 1981-03-20

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1981-03-20
Product CodeKBC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUTO SUTURE PSS SKIN STAPLING INSTRUMENT 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 1981-03-20 under 510(k) number K810187. The device is classified under product code KBC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SUTURE PSS SKIN STAPLING INSTRUMENT?

AUTO SUTURE PSS SKIN STAPLING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K810187.

When did AUTO SUTURE PSS SKIN STAPLING INSTRUMENT receive FDA 510(k) clearance?

AUTO SUTURE PSS SKIN STAPLING INSTRUMENT received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810187.

Who is the listed applicant for AUTO SUTURE PSS SKIN STAPLING INSTRUMENT?

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 PSS SKIN STAPLING INSTRUMENT?

The FDA product code for AUTO SUTURE PSS SKIN STAPLING INSTRUMENT is KBC.

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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: KBC)

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.

K811887SKIN STAPLE EXTRACTORSierra Laboratories, Inc.K810188AUTO SUTURE GAS POWERED DISP. LDS STAPLUnited States Surgical, A Division of Tyco HealthcK772379JOSEPH SAWEdward Weck, 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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