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FDA 510(k)

PROXIMATE*II DISPOSABLE SKIN STAPLER

K-Number: K803038 · 1980-12-30

ApplicantETHICON, Inc.
Decision Date1980-12-30
Product CodeGAG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROXIMATE*II DISPOSABLE SKIN STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K803038. 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 PROXIMATE*II DISPOSABLE SKIN STAPLER?

PROXIMATE*II DISPOSABLE SKIN STAPLER is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is ETHICON, Inc.. The 510(k) number is K803038.

When did PROXIMATE*II DISPOSABLE SKIN STAPLER receive FDA 510(k) clearance?

PROXIMATE*II DISPOSABLE SKIN STAPLER received FDA 510(k) clearance on 1980-12-30, under 510(k) number K803038.

Who is the listed applicant for PROXIMATE*II DISPOSABLE SKIN STAPLER?

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

What is the FDA product code for PROXIMATE*II DISPOSABLE SKIN STAPLER?

The FDA product code for PROXIMATE*II DISPOSABLE SKIN STAPLER is GAG.

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Other records listing ETHICON, Inc. as applicant

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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

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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