FDA 510(k)

PI-PNEUMO INTESTINAL STAPLING CARTRIDGE

K-Number: K851122 · 1985-04-25

Decision Date1985-04-25

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PI-PNEUMO INTESTINAL STAPLING CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Surgeons Choice, Inc.. It received FDA 510(k) clearance on 1985-04-25 under 510(k) number K851122. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PI-PNEUMO INTESTINAL STAPLING CARTRIDGE?

PI-PNEUMO INTESTINAL STAPLING CARTRIDGE is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Surgeons Choice, Inc.. The 510(k) number is K851122.

When did PI-PNEUMO INTESTINAL STAPLING CARTRIDGE receive FDA 510(k) clearance?

PI-PNEUMO INTESTINAL STAPLING CARTRIDGE received FDA 510(k) clearance on 1985-04-25, under 510(k) number K851122.

Who is the listed applicant for PI-PNEUMO INTESTINAL STAPLING CARTRIDGE?

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

What is the FDA product code for PI-PNEUMO INTESTINAL STAPLING CARTRIDGE?

The FDA product code for PI-PNEUMO INTESTINAL STAPLING CARTRIDGE is GDW.

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Other records listing Surgeons Choice, Inc. as applicant

K851121PI-PHEUMO INTESTINAL INSTRUMENT SET K843399SURGEONS CHOICE PI VASCULAR STAPLING K830768DISPOSABLE SKIN STAPLER K823776PI-PNEUMO-INTESTINAL INSTRUMENT SET K813170ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER

Related Devices (Code: GDW)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.