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FDA 510(k)

PI-PHEUMO INTESTINAL INSTRUMENT SET

K-Number: K851121 · 1985-04-25

ApplicantSurgeons Choice, Inc.
Decision Date1985-04-25
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PI-PHEUMO INTESTINAL INSTRUMENT SET 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 K851121. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PI-PHEUMO INTESTINAL INSTRUMENT SET?

PI-PHEUMO INTESTINAL INSTRUMENT SET 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 K851121.

When did PI-PHEUMO INTESTINAL INSTRUMENT SET receive FDA 510(k) clearance?

PI-PHEUMO INTESTINAL INSTRUMENT SET received FDA 510(k) clearance on 1985-04-25, under 510(k) number K851121.

Who is the listed applicant for PI-PHEUMO INTESTINAL INSTRUMENT SET?

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-PHEUMO INTESTINAL INSTRUMENT SET?

The FDA product code for PI-PHEUMO INTESTINAL INSTRUMENT SET is GAG.

Related Clinical Trials

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Other records listing Surgeons Choice, Inc. 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.

K851122PI-PNEUMO INTESTINAL STAPLING CARTRIDGEK843399SURGEONS CHOICE PI VASCULAR STAPLINGK830768DISPOSABLE SKIN STAPLERK823776PI-PNEUMO-INTESTINAL INSTRUMENT SETK813170ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER

Related Devices (Code: GAG)

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.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLCK251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.

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.

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