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FDA 510(k)

DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES

K-Number: K934105 · 1994-03-28

ApplicantSurgical Innovations Corp.
Decision Date1994-03-28
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Corp.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K934105. 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 DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES?

DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Surgical Innovations Corp.. The 510(k) number is K934105.

When did DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES receive FDA 510(k) clearance?

DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES received FDA 510(k) clearance on 1994-03-28, under 510(k) number K934105.

Who is the listed applicant for DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES?

The FDA 510(k) record lists Surgical Innovations Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES?

The FDA product code for DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES is GAG.

Related Clinical Trials

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.

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Other records listing Surgical Innovations Corp. 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.

K944292SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLEK914098LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR

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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