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FDA 510(k)

SKIN STAPLE EXTRACTOR

K-Number: K811887 · 1981-07-27

ApplicantSierra Laboratories, Inc.
Decision Date1981-07-27
Product CodeKBC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SKIN STAPLE EXTRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Sierra Laboratories, Inc.. It received FDA 510(k) clearance on 1981-07-27 under 510(k) number K811887. 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 SKIN STAPLE EXTRACTOR?

SKIN STAPLE EXTRACTOR is a medical device that received FDA 510(k) clearance on 1981-07-27. The listed applicant is Sierra Laboratories, Inc.. The 510(k) number is K811887.

When did SKIN STAPLE EXTRACTOR receive FDA 510(k) clearance?

SKIN STAPLE EXTRACTOR received FDA 510(k) clearance on 1981-07-27, under 510(k) number K811887.

Who is the listed applicant for SKIN STAPLE EXTRACTOR?

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

What is the FDA product code for SKIN STAPLE EXTRACTOR?

The FDA product code for SKIN STAPLE EXTRACTOR is KBC.

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Other records listing Sierra Laboratories, Inc. as applicant

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K970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERK962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERK962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERK934266COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETERK934052ALPINE REUSABLE LEG BAGSK931156CONE CATH

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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.

K810188AUTO SUTURE GAS POWERED DISP. LDS STAPLUnited States Surgical, A Division of Tyco HealthcK810187AUTO SUTURE PSS SKIN STAPLING INSTRUMENTUnited 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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